Intracranial NeoplasmPhase 2UC-GlioFETNCT04044937
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
A Phase 2 study testing F-18 Fluoroethyltyrosine (FET) and Positron Emission Tomography (PET) in people with Intracranial Neoplasm and Low Grade Glioma, run by Thomas Hope at 1 site in United States.
Trial summary
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Intracranial Neoplasm, Low Grade Glioma, Recurrent Glioblastoma
- What is being tested?
- F-18 Fluoroethyltyrosine (FET) and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 3 years.
- Presence or suspicion of intracranial neoplasm in two populations.
- Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered:
- Recurrent metastatic lesions.
- Recurrent high-grade gliomas (grades 3 and 4).
- Recurrent low-grade gliomas (grades 1 and 2).
- Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.
Who cannot join
- Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
- Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
- Sedation or anesthesia can be used for patients who cannot tolerate the exam.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if FET PET can differentiate between benign treatment-related changes (TRC) and recurrent glioma in comparison to a composite standard of truth (CSOT) that includes pathology and other clinical information, evaluated using estimates of sensitivity and specificity (Combined populations)
SECONDARY OBJECTIVES:
- To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.(Combined populations).
II. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a CSOT evaluated using estimates other than subject-based sensitivity and specificity.(Combined populations).
III. To assess the safety of FET PET, as determined by treatment emergent adverse events (TEAEs) within 48 hours of FET administration.(Combined populations).
IV. To describe the inter-reader variability between 3 independent blinded readers of FET PET images in assessments of benign TRC versus recurrent glioma.(Combined populations).
- To describe intra-reader variability between 3 independent blinded readers of FET PET images in the assessments of benign TRC versus recurrent glioma.(Combined populations).
EXPLORATORY OBJECTIVES:
- To assess relationships between serial FET PET and clinical outcome (benign TRC and recurrence) in patients with recurrent metastatic lesions, recurrent high grade gliomas and recurrent low-grade gliomas.
II. To determine if MRI can differentiate between benign treatment-related changes and recurrence.
III. To describe the distribution of the standardized uptake value (SUV) and tumor-to-background ratio (TBR) for observed lesions.
IV. To determine if FET PET can differentiate between benign TRC and recurrent metastatic lesions.
- To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas (Population 2).
OUTLINE:
Participants receive F-18 fluoroethyltyrosine intravenously (IV) over approximately 1 minute and undergo PET over 40 minutes. After completion of study treatment, participants are followed up periodically.
- Conditions
- Intracranial Neoplasm, Low Grade Glioma, Recurrent Glioblastoma, Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma
- Being tested
- F-18 Fluoroethyltyrosine (FET), Positron Emission Tomography (PET)
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 Fluoroethyltyrosine (FET)Drug
Also called 18F-FET, 18FET, 2''-[F18] Fluoro-ethyl-L-tyrosine, [18F]-Fluoro-ethyl-L-tyrosine
Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner
Positron Emission Tomography (PET)Procedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography
All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.
| Study group | Role | What they receive |
|---|---|---|
| Population 1: Intracranial neoplasms (glial or metastatic disease) | Experimental | Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients. Receives: Drug: F-18 Fluoroethyltyrosine (FET); Procedure: Positron Emission Tomography (PET) |
| Population 2: Suspected glial neoplasms | Experimental | Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients. Receives: Drug: F-18 Fluoroethyltyrosine (FET); Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)
Sensitivity is defined as a percentage of all participants with a true positive (TP) FET PET scan result relative to participants with a positive CSOT result = [TP / (TP + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Measured: Up to 6 months
Specificity of FET PET using a CSOT (subject-level)
Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to participants with a negative CSOT result = [TN / (TN + FP)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Measured: Up to 6 months
Secondary outcomes (25)
Sensitivity of FET PET using a histopathology standard of truth (subject-level)
Sensitivity is defined as percentage of all participants with a true positive (TP) FET PET scan result relative to all participants with a positive histological result = [TP / (TP + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
Measured: Up to 6 months
Sensitivity of FET PET using a histopathology standard of truth (lesion-level)
Sensitivity is defined as percentage of all lesions with a true positive (TP) FET PET scan result relative to all lesions with a positive histological result = [TP / (TP + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
Measured: Up to 6 months
Specificity of FET PET using a histopathology standard of truth (subject-level)
Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to all participants with a negative histological result = [TN / (TN + FP)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
Measured: Up to 6 months
Specificity of FET PET using a histopathology standard of truth (lesion-level)
Specificity is defined as percentage of all lesions with a true negative (TN) scan result relative to all lesions with a negative histological result = [TN / (TN + FP)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
Measured: Up to 6 months
Positive Predictive Value (PPV) using a histopathology standard of truth (subject-level)
The positive predictive value for all participants is defined as the probability that a positive histological standard of truth result is obtained given that the result of the FET PET scan is positive and reported as a percentage across all participants = [TP / (TP + FP)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
Measured: Up to 6 months
Positive Predictive Value (PPV) using a histopathology standard of truth (lesion-level)
The positive predictive value for all lesions is defined as the probability that a positive histological standard of truth result is obtained given that the result of the FET PET scan is positive and reported as a percentage of all lesions = [TP / (TP + FP)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
Measured: Up to 6 months
Negative Predictive Value (NPV) using a histopathology standard of truth (subject-level)
The negative predictive value for all participants is defined as the probability that a negative standard of truth result is obtained given that the result of the FET PET scan is negative and reported as a percentage of all participants = [TN / (TN + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
Measured: Up to 6 months
Negative Predictive Value (NPV) using a histopathology standard of truth (lesion-level)
The negative predictive value for all lesions is defined as the probability that a negative standard of truth result is obtained given that the result of the FET PET scan is negative and reported as a percentage of all lesions = [TN / (TN + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
Measured: Up to 6 months
Accuracy of FET PET using a histopathology standard of truth (subject-level)
The accuracy is defined as the probability that the FET PET scan result for all participants is correct using histopathological results and reported as a percentage: Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
Measured: Up to 6 months
Accuracy of FET PET using a histopathology standard of truth (lesion-level)
The accuracy is defined as the probability that the FET PET scan result for all lesions is correct using histopathological results and reported as a percentage: Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
Measured: Up to 6 months
Misclassification rate for FET PET using a histopathology standard of truth (Subject-level)
The misclassification rate is defined as the probability that the FET PET scan result for all participants is not correct using histopathological results and reported as a percentage: Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
Measured: Up to 6 months
Misclassification rate for FET PET using a histopathology standard of truth (lesion-level)
The misclassification rate is defined as the probability that the FET PET scan result for all lesions is not correct using histopathological results and reported as a percentage: Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100. For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
Measured: Up to 6 months
Sensitivity of FET PET using a CSOT (lesion-level)
Sensitivity is defined as a percentage of all lesions with a true positive (TP) FET PET scan result relative to lesions with a positive CSOT result = [TP / (TP + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion.
Measured: Up to 6 months
Specificity of FET PET using a CSOT (lesion-level)
Specificity is defined as percentage of all lesions with a true negative (TN) FET PET scan result relative to lesions with a negative CSOT result = [TN / (TN + FP)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion.
Measured: Up to 6 months
PPV of FET PET using a CSOT (subject-level)
The positive predictive value is defined as the probability that a positive CSOT result is obtained given that the result of the FET PET scan is positive, PPV (%) = [TP / (TP + FP)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Measured: Up to 6 months
PPV of FET PET using a CSOT (lesion-level)
The positive predictive value is defined as the probability that a CSOT result is obtained given that the result of the FET PET scan is positive PPV (%) = [TP / (TP + FP)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion.
Measured: Up to 6 months
NPV of FET PET using a CSOT (subject-level)
The negative predictive value is defined as the probability that a negative CSOT result is obtained given that the result of the FET PET scan is negative, NPV (%) = [TN / (TN + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Measured: Up to 6 months
NPV of FET PET using a CSOT (lesion-level)
The negative predictive value is defined as the probability that a negative CSOT result is obtained given that the result of the FET PET scan is negative, NPV (%) = [TN / (TN + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion.
Measured: Up to 6 months
Accuracy of FET PET using a CSOT (subject-level)
The accuracy is defined as the probability that the FET PET scan result is correct, Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Measured: Up to 6 months
Accuracy of FET PET using a CSOT (lesion-level)
The accuracy is defined as the probability that the FET PET scan result is correct, Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion.
Measured: Up to 6 months
Misclassification rate for FET PET using CSOT (subject-level)
The misclassification rate is defined as the probability that the FET PET scan result is not correct, Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Measured: Up to 6 months
Misclassification rate for FET PET using CSOT (lesion-level)
The misclassification rate is defined as the probability that the FET PET scan result is not correct, Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion.
Measured: Up to 6 months
Degree of inter-rater reliability
Inter-reader variability will be analyzed using Fleiss' kappa statistic to determine the agreement between three independent blinded readers in assessing FET PET images as recurrence or TRC. Fleiss's kappa ranges from 0 to 1, where 0 indicates no agreement beyond chance, 1 indicates perfect agreement among all raters.
Measured: Up to 6 months
Reproducibility of inter-rater reliability
Intra-reader variability will be analyzed based on a random sample of 15 subjects whose images were re- reviewed by the same reader. The percent of agreement between the two interpretations will be computed for each reader. Cohen's kappa statistics will be used to determine the reproducibility of the assessment by individual readers when analyzing the same data repeatedly. Cohen's Kappa ranges from -1 to 1, where-1 indicates complete disagreement between raters, 0 indicates agreement no better than chance, 1 indicates complete agreement between raters.
Measured: Up to 6 months
Proportion of all participants with reported treatment-emergent adverse events (TEAEs)
The proportion of all participants who have reported grade 3 and above adverse events after receiving interventional scan will be recorded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4 will be reported.
Measured: Up to 48 hours after FET PET imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start29 Oct 2018
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas A Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044937
- Sponsor's protocol ID
- 171022
- Other IDs
- NCI-2018-01875
- Acronym
- UC-GlioFET
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2019
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
- ClinicalTrials.gov ID
- NCT04044937
- Acronym / sponsor ID
- UC-GlioFET / 171022
- Conditions
- Intracranial Neoplasm, Low Grade Glioma, Recurrent Glioblastoma, Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.
Detailed description
PRIMARY OBJECTIVES:
- To determine if FET PET can differentiate between benign treatment-related changes (TRC) and recurrent glioma in comparison to a composite standard of truth (CSOT) that includes pathology and other clinical information, evaluated using estimates of sensitivity and specificity (Combined populations)
SECONDARY OBJECTIVES:
- To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.(Combined populations).
II. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a CSOT evaluated using estimates other than subject-based sensitivity and specificity.(Combined populations).
III. To assess the safety of FET PET, as determined by treatment emergent adverse events (TEAEs) within 48 hours of FET administration.(Combined populations).
IV. To describe the inter-reader variability between 3 independent blinded readers of FET PET images in assessments of benign TRC versus recurrent glioma.(Combined populations).
- To describe intra-reader variability between 3 independent blinded readers of FET PET images in the assessments of benign TRC versus recurrent glioma.(Combined populations).
EXPLORATORY OBJECTIVES:
- To assess relationships between serial FET PET and clinical outcome (benign TRC and recurrence) in patients with recurrent metastatic lesions, recurrent high grade gliomas and recurrent low-grade gliomas.
II. To determine if MRI can differentiate between benign treatment-related changes and recurrence.
III. To describe the distribution of the standardized uptake value (SUV) and tumor-to-background ratio (TBR) for observed lesions.
IV. To determine if FET PET can differentiate between benign TRC and recurrent metastatic lesions.
- To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas (Population 2).
OUTLINE:
Participants receive F-18 fluoroethyltyrosine intravenously (IV) over approximately 1 minute and undergo PET over 40 minutes. After completion of study treatment, participants are followed up periodically.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population 1: Intracranial neoplasms (glial or metastatic disease) | Experimental | Drug: F-18 Fluoroethyltyrosine (FET), Procedure: Positron Emission Tomography (PET)Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients. |
| Population 2: Suspected glial neoplasms | Experimental | Drug: F-18 Fluoroethyltyrosine (FET), Procedure: Positron Emission Tomography (PET)Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 3 years.
- Presence or suspicion of intracranial neoplasm in two populations.
Key exclusion criteria (3 listed)
- Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
- Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18 Fluoroethyltyrosine (FET)Also: 18F-FET, 18FET, 2''-[F18] Fluoro-ethyl-L-tyrosine, [18F]-Fluoro-ethyl-L-tyrosinePatients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner | Drug | Population 1: Intracranial neoplasms (glial or metastatic disease), Population 2: Suspected glial neoplasms |
| Positron Emission Tomography (PET)Also: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission TomographyAll patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients. | Procedure or surgery | Population 1: Intracranial neoplasms (glial or metastatic disease), Population 2: Suspected glial neoplasms |
Primary outcome
Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)
Time frame: Up to 6 months
Sensitivity is defined as a percentage of all participants with a true positive (TP) FET PET scan result relative to participants with a positive CSOT result = [TP / (TP + FN)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
Specificity of FET PET using a CSOT (subject-level)
Time frame: Up to 6 months
Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to participants with a negative CSOT result = [TN / (TN + FP)] x 100. The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data. Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging. Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. For lesion-level standards, features of RANO will be considered. Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data. From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
25 secondary outcomes
Sensitivity of FET PET using a histopathology standard of truth (subject-level)
Time frame: Up to 6 months
Sensitivity of FET PET using a histopathology standard of truth (lesion-level)
Time frame: Up to 6 months
Specificity of FET PET using a histopathology standard of truth (subject-level)
Time frame: Up to 6 months
Specificity of FET PET using a histopathology standard of truth (lesion-level)
Time frame: Up to 6 months
Positive Predictive Value (PPV) using a histopathology standard of truth (subject-level)
Time frame: Up to 6 months
Positive Predictive Value (PPV) using a histopathology standard of truth (lesion-level)
Time frame: Up to 6 months
Negative Predictive Value (NPV) using a histopathology standard of truth (subject-level)
Time frame: Up to 6 months
Negative Predictive Value (NPV) using a histopathology standard of truth (lesion-level)
Time frame: Up to 6 months
Accuracy of FET PET using a histopathology standard of truth (subject-level)
Time frame: Up to 6 months
Accuracy of FET PET using a histopathology standard of truth (lesion-level)
Time frame: Up to 6 months
Misclassification rate for FET PET using a histopathology standard of truth (Subject-level)
Time frame: Up to 6 months
Misclassification rate for FET PET using a histopathology standard of truth (lesion-level)
Time frame: Up to 6 months
Sensitivity of FET PET using a CSOT (lesion-level)
Time frame: Up to 6 months
Specificity of FET PET using a CSOT (lesion-level)
Time frame: Up to 6 months
PPV of FET PET using a CSOT (subject-level)
Time frame: Up to 6 months
PPV of FET PET using a CSOT (lesion-level)
Time frame: Up to 6 months
NPV of FET PET using a CSOT (subject-level)
Time frame: Up to 6 months
NPV of FET PET using a CSOT (lesion-level)
Time frame: Up to 6 months
Accuracy of FET PET using a CSOT (subject-level)
Time frame: Up to 6 months
Accuracy of FET PET using a CSOT (lesion-level)
Time frame: Up to 6 months
Misclassification rate for FET PET using CSOT (subject-level)
Time frame: Up to 6 months
Misclassification rate for FET PET using CSOT (lesion-level)
Time frame: Up to 6 months
Degree of inter-rater reliability
Time frame: Up to 6 months
Reproducibility of inter-rater reliability
Time frame: Up to 6 months
Proportion of all participants with reported treatment-emergent adverse events (TEAEs)
Time frame: Up to 48 hours after FET PET imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-18 Fluoroethyltyrosine (FET) and Positron Emission Tomography (PET) in people with Intracranial Neoplasm and Low Grade Glioma, run by Thomas Hope at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level) (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.