Intracranial NeoplasmNCT06474533
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
An observational study of Intracranial Neoplasm, run by Thomas Hope at 1 site in United States.
Trial summary
This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Intracranial Neoplasm
- What is being tested?
- Fluorethyltyrosine (18-F) and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).
Who may be able to join
- Presence or suspicion of intracranial neoplasm in two populations:
- Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.
- Three sub-populations will be considered:
- Recurrent metastatic lesions.
- Recurrent high-grade gliomas (Grades 3 and 4).
- Recurrent low-grade gliomas (Grade 2).
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- Population 2: Participants prior to primary treatment with planned biopsy or surgical resection.
- Age > 3 years.
- Participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.
Who cannot join
- Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.
- Participants 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 participants who cannot tolerate the exam.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Louise Magat, 415-502-1822, Louise.Magat@ucsf.edu
(887) 827-3222, cancertrials@ucsf.edu
About this study
This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas.
- To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2.
SECONDARY OBJECTIVES:
- To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1.
- To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.
EXPLORATORY OBJECTIVES:
- To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas.
OUTLINE:
Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET. Adult participants may undergo up to two repeat FET PET scans. Adverse events will be recorded.
- Conditions
- Intracranial Neoplasm
- Being tested
- Fluorethyltyrosine (18-F), Positron Emission Tomography (PET)
- Keywords
- Imaging Studies
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorethyltyrosine (18-F)Drug
Also called Fluoroethyltyrosine (FET), FET, O-(2-[18F]fluoroethyl)-L-tyrosine (FET)
Given intravenously (IV)
Positron Emission Tomography (PET)Procedure or surgery
Also called PET scan, PET
Undergo Imaging Procedure
| Study group | Role | What they receive |
|---|---|---|
| Population 1: Participants with intracranial neoplasms | Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging. Receives: Drug: Fluorethyltyrosine (18-F); Procedure: Positron Emission Tomography (PET) | |
| Population 2: Participants with suspected glial neoplasms | Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery) Receives: Drug: Fluorethyltyrosine (18-F); Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Intracranial lesion tumor-to-background ratio (TBRmax)
The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue.
Measured: Up to 3 years
Percentage of accurate prediction of presence of tumor (Population 1)
The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported
Measured: Up to 3 years
Percentage of radiological read responses
The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start21 Jun 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (estimated)
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
- Michael Thomas, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474533
- Sponsor's protocol ID
- 24924
- Other IDs
- NCI-2024-04996
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2024
- Last updated
- 27 Aug 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 27 Aug 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
- NCT06474533
- Acronym / sponsor ID
- 24924
- Conditions
- Intracranial Neoplasm
- Keywords
- Imaging Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Jun 2024 (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 is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.
Detailed description
PRIMARY OBJECTIVES:
- To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas.
- To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2.
SECONDARY OBJECTIVES:
- To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1.
- To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.
EXPLORATORY OBJECTIVES:
- To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas.
OUTLINE:
Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET. Adult participants may undergo up to two repeat FET PET scans. Adverse events will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population 1: Participants with intracranial neoplasms | – | Drug: Fluorethyltyrosine (18-F), Procedure: Positron Emission Tomography (PET)Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging. |
| Population 2: Participants with suspected glial neoplasms | – | Drug: Fluorethyltyrosine (18-F), Procedure: Positron Emission Tomography (PET)Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery) |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).
Key inclusion criteria (9 listed)
- Presence or suspicion of intracranial neoplasm in two populations:
- Age > 3 years.
- Participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.
Key exclusion criteria (3 listed)
- Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.
- Participants 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 |
|---|---|---|
| Fluorethyltyrosine (18-F)Also: Fluoroethyltyrosine (FET), FET, O-(2-[18F]fluoroethyl)-L-tyrosine (FET)Given intravenously (IV) | Drug | Population 1: Participants with intracranial neoplasms, Population 2: Participants with suspected glial neoplasms |
| Positron Emission Tomography (PET)Also: PET scan, PETUndergo Imaging Procedure | Procedure or surgery | Population 1: Participants with intracranial neoplasms, Population 2: Participants with suspected glial neoplasms |
Primary outcome
Maximum Intracranial lesion tumor-to-background ratio (TBRmax)
Time frame: Up to 3 years
The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue.
Percentage of accurate prediction of presence of tumor (Population 1)
Time frame: Up to 3 years
The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported
Percentage of radiological read responses
Time frame: Up to 3 years
The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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.
Michael Thomas, 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?
An observational study of Intracranial Neoplasm, 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 9 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: looking for participants now, as of the sponsor's last update on 27 Aug 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Magat ((415) 502-1822, Louise.Magat@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Intracranial lesion tumor-to-background ratio (TBRmax) (time frame: Up to 3 years). The study lists 3 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 27 Aug 2026.