GlioblastomaEarly Phase 1NCT04315584
FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
A Early Phase 1 study testing Positron Emission Tomography, Computed Tomography and Multiparametric Magnetic Resonance Imaging Scan in people with Glioblastoma, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this pilot study will be to conduct a clinical trial using a time-of-flight PET scanner and MRI scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Positron Emission Tomography, Computed Tomography and Multiparametric Magnetic Resonance Imaging Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 20 Jun 2024
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Known or suspected recurrent malignant brain tumors
- Radiographic worsening reported on MRI shortly (within 3 months) after completion of radiation and temozolomide therapy
- Able to lie flat and/or still for a minimum of 60 minutes
- Willingness and ability to comply with scheduled visits and study procedures
- Patients who have a clinical indication for a PET-CT
- If female, patient must be postmenopausal or surgically sterile
Who cannot join
- Conditions that preclude a clinical brain FDG PET study, including: Consumption of liquids with sugar and/or caffeine prior to the study, Blood glucose levels over 150 mg/mL, Eating or drinking calories of any type within 4 hours of radiotracer injection, Hyperinsulinemia, Patients who for any reason cannot tolerate lying supine for 60 minutes
- Conditions that preclude a FDOPA PET study, including: Consuming a diet that is NOT low in protein after the previous evening meal
- Tumor located in the striatum
- Changes in medication (new prescriptions or change in dosages) between visits 1 and 2
- Pregnant, nursing, or lactating
- Women of childbearing potential (premenopausal female capable of becoming pregnant), which also includes:
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- women on oral, injectable, or mechanical contraceptives, women who are single, women whose male partners have been vasectomized or whose male partners have received or are utilizing mechanical contraceptive devices
- Weight > 450 lbs
- Known allergic reactions to 3,4-dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-FDOPA) and Fluorine-18 fluorodeoxyglucose (18F-FDG)
- Confirmation that study eligibility criteria have not been met between visits 1 and 2
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Florence Yan, 434-243-6768, fty5jf@hscmail.mcc.virginia.edu
Bijoy Kundu, PhD
About this study
The purpose of this pilot study will be to conduct a clinical trial using a time-of-flight PET scanner and MRI scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients. We will attempt to do so by performing a static and dynamic FDG-PET scan, a static and dynamic FDOPA-PET scan, and a multiparametric MRI scan - then comparing the results with surgical pathology and static FDG-PET scans. We hypothesize that the new quantitative kinetic analytical methods using FDOPA in combination with FDG will provide crucial functional information to distinguish recurrent tumors from treatment-induced radiation changes in patients with treated brain neoplasms. This is important for improving patient outcomes by allowing treating physicians to more accurately tailor treatments. Furthermore, dynamic FDG and FDOPA PET will be combined with high resolution anatomic and physiologic MRI in order to develop a multimodal multiparametric approach for differentiating tumor recurrence from treatment effect.
Read the detailed description
PRIMARY OBJECTIVES:
- The primary objective will be to evaluate the diagnostic accuracy of Dynamic PET imaging in differentiating tumor recurrence from treatment effect (radiation necrosis or pseudoprogression) in patients previously treated with chemo-radiation therapy for primary high grade gliomas. This will be accomplished by examining the concordance between the Dynamic PET imaging prediction and the criterion standard, which will be based on either surgical pathology or an integrated clinical/MRI determination within a 3-6 month interval after Dynamic PET imaging.
SECONDARY OBJECTIVES:
- The diagnostic accuracy of Static PET imaging, advanced MRI, and advanced MRI + Dynamic PET imaging in differentiating tumor recurrence from radiation-induced necrosis in high grade glioma patients will be examined in the same exact way as just outlined for Dynamic PET imaging.
OUTLINE:
Subjects receive 18FDG (first scan) and (18)F-FDOPA (2-14 days from the first scan) intravenously (IV) slowly over a period of 15-20 seconds and then undergo dynamic PET scans over a period of 60-90 minutes. CT scans on the subjects are performed before the dynamic PET scans for 5 minutes. Subjects also undergo MRI brain examinations just prior to the FDOPA scan over a period of 1 hour, which includes T1 weighed, T1 weighted contrast enhanced, T2 weighted, Diffusion tensor imaging, MR spectroscopy, and Dynamic susceptibility contrast perfusion weighted (DSC-PWI) imaging.
- Conditions
- Glioblastoma
- Being tested
- Positron Emission Tomography, Computed Tomography, Multiparametric Magnetic Resonance Imaging Scan, Fludeoxyglucose F-18, fluorine F 18 fluorodopa
- Keywords
- glioblastoma, PET, CT, multiparametric MRI, brain imaging, tumor recurrence
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission TomographyProcedure or surgery
Also called PET, PET Scan, Positron Emission Tomography Scan, Medical Imaging, Positron Emission Tomography
Undergo PET/CT Scans
Computed TomographyProcedure or surgery
Also called CT, CT Scan, Computerized Axial Tomography, CAT
Undergo PET/CT Scans
Multiparametric Magnetic Resonance Imaging ScanProcedure or surgery
Also called mpMRI, multiparametric MRI
Undergo a multiparametric MRI scan
Fludeoxyglucose F-18Radiation
Also called FDG, 18 FDG, fludeoxyglucose F 18, 2-F18-fluoro-2-deoxy-D-glucose
IV (intravenous) administration of radiotracer
fluorine F 18 fluorodopaRadiation
Also called 18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPA, 3,4-dihydroxy-6-(18)F-fluoro-l-phenylalanine
IV (intravenous) administration of radiotracer
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Study subjects will receive 18FDG via an IV before undergoing one PET/CT scan over 60 minutes. They will then receive an IV injection of Gadovist for contrast before undergoing a multiparametric MRI scan. Subjects will also receive (18)F-FDOPA via an IV before undergoing another PET/CT scan over 60 minutes. Receives: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Multiparametric Magnetic Resonance Imaging Scan; Radiation: Fludeoxyglucose F-18; Radiation: fluorine F 18 fluorodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative parametric maps indicating differences in rates of glucose and amino acid uptake (Ki) obtained from dynamic FDG and FDOPA scans respectively.
Will be derived from PET/CT scan imaging.
Measured: Up to 6 months
Quantitative parametric maps indicating differences in details (d) components of the wavelet transform analysis, d6 and d8, based on established tumor feature criterions.
Will be derived from MRI brain scan imaging.
Measured: Up to 6 months
Semi-quantitative standardize uptake value (SUV) parametric maps based on static PET scans (last 20 minutes of the dynamic PET scans).
Will be derived from PET/CT scan imaging.
Measured: Up to 6 months
MRI brain metrics
Including anatomic assessment based on T1, T2, and contrast enhanced T1 weighted imaging, MR spectroscopy data (choline, creatinine, and N-acetyl acetate peak integrals and ratios), MR perfusion data (relative cerebral blood volume), and diffusion tensor imaging data (apparent diffusion coefficient, fractional anisotropy)
Measured: Up to 6 months
Surgical pathology or 3-6 month interval multidisciplinary clinical evaluation.
To be compared with the imaging analyses for comparing ability to differentiate tumor recurrence from radiation necrosis.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start15 Mar 2020 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All 5 study subjects will undergo the same procedures.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bijoy Kundu, University of Virginia
- Investigators
- Bijoy Kundu, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315584
- Sponsor's protocol ID
- HSR190096
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
- ClinicalTrials.gov ID
- NCT04315584
- Acronym / sponsor ID
- HSR190096
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, PET, CT, multiparametric MRI, brain imaging, tumor recurrence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 19 Mar 2020 (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.
The purpose of this pilot study will be to conduct a clinical trial using a time-of-flight PET scanner and MRI scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients. We will attempt to do so by performing a static and dynamic FDG-PET scan, a static and dynamic FDOPA-PET scan, and a multiparametric MRI scan - then comparing the results with surgical pathology and static FDG-PET scans. We hypothesize that the new quantitative kinetic analytical methods using FDOPA in combination with FDG will provide crucial functional information to distinguish recurrent tumors from treatment-induced radiation changes in patients with treated brain neoplasms. This is important for improving patient outcomes by allowing treating physicians to more accurately tailor treatments. Furthermore, dynamic FDG and FDOPA PET will be combined with high resolution anatomic and physiologic MRI in order to develop a multimodal multiparametric approach for differentiating tumor recurrence from treatment effect.
Detailed description
PRIMARY OBJECTIVES:
- The primary objective will be to evaluate the diagnostic accuracy of Dynamic PET imaging in differentiating tumor recurrence from treatment effect (radiation necrosis or pseudoprogression) in patients previously treated with chemo-radiation therapy for primary high grade gliomas. This will be accomplished by examining the concordance between the Dynamic PET imaging prediction and the criterion standard, which will be based on either surgical pathology or an integrated clinical/MRI determination within a 3-6 month interval after Dynamic PET imaging.
SECONDARY OBJECTIVES:
- The diagnostic accuracy of Static PET imaging, advanced MRI, and advanced MRI + Dynamic PET imaging in differentiating tumor recurrence from radiation-induced necrosis in high grade glioma patients will be examined in the same exact way as just outlined for Dynamic PET imaging.
OUTLINE:
Subjects receive 18FDG (first scan) and (18)F-FDOPA (2-14 days from the first scan) intravenously (IV) slowly over a period of 15-20 seconds and then undergo dynamic PET scans over a period of 60-90 minutes. CT scans on the subjects are performed before the dynamic PET scans for 5 minutes. Subjects also undergo MRI brain examinations just prior to the FDOPA scan over a period of 1 hour, which includes T1 weighed, T1 weighted contrast enhanced, T2 weighted, Diffusion tensor imaging, MR spectroscopy, and Dynamic susceptibility contrast perfusion weighted (DSC-PWI) imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All 5 study subjects will undergo the same procedures.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Procedure: Multiparametric Magnetic Resonance Imaging Scan, Radiation: Fludeoxyglucose F-18, Radiation: fluorine F 18 fluorodopaStudy subjects will receive 18FDG via an IV before undergoing one PET/CT scan over 60 minutes. They will then receive an IV injection of Gadovist for contrast before undergoing a multiparametric MRI scan. Subjects will also receive (18)F-FDOPA via an IV before undergoing another PET/CT scan over 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18
- Known or suspected recurrent malignant brain tumors
- Radiographic worsening reported on MRI shortly (within 3 months) after completion of radiation and temozolomide therapy
- Able to lie flat and/or still for a minimum of 60 minutes
- Willingness and ability to comply with scheduled visits and study procedures
Key exclusion criteria (10 listed)
- Conditions that preclude a clinical brain FDG PET study, including: Consumption of liquids with sugar and/or caffeine prior to the study, Blood glucose levels over 150 mg/mL, Eating or drinking calories of any type within 4 hours of radiotracer injection, Hyperinsulinemia, Patients who for any reason cannot tolerate lying supine for 60 minutes
- Conditions that preclude a FDOPA PET study, including: Consuming a diet that is NOT low in protein after the previous evening meal
- Tumor located in the striatum
- Changes in medication (new prescriptions or change in dosages) between visits 1 and 2
- Pregnant, nursing, or lactating
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 |
|---|---|---|
| Positron Emission TomographyAlso: PET, PET Scan, Positron Emission Tomography Scan, Medical Imaging, Positron Emission TomographyUndergo PET/CT Scans | Procedure or surgery | Diagnostic |
| Computed TomographyAlso: CT, CT Scan, Computerized Axial Tomography, CATUndergo PET/CT Scans | Procedure or surgery | Diagnostic |
| Multiparametric Magnetic Resonance Imaging ScanAlso: mpMRI, multiparametric MRIUndergo a multiparametric MRI scan | Procedure or surgery | Diagnostic |
| Fludeoxyglucose F-18Also: FDG, 18 FDG, fludeoxyglucose F 18, 2-F18-fluoro-2-deoxy-D-glucoseIV (intravenous) administration of radiotracer | Radiation | Diagnostic |
| fluorine F 18 fluorodopaAlso: 18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPA, 3,4-dihydroxy-6-(18)F-fluoro-l-phenylalanineIV (intravenous) administration of radiotracer | Radiation | Diagnostic |
Primary outcome
Quantitative parametric maps indicating differences in rates of glucose and amino acid uptake (Ki) obtained from dynamic FDG and FDOPA scans respectively.
Time frame: Up to 6 months
Will be derived from PET/CT scan imaging.
Quantitative parametric maps indicating differences in details (d) components of the wavelet transform analysis, d6 and d8, based on established tumor feature criterions.
Time frame: Up to 6 months
Will be derived from MRI brain scan imaging.
Semi-quantitative standardize uptake value (SUV) parametric maps based on static PET scans (last 20 minutes of the dynamic PET scans).
Time frame: Up to 6 months
Will be derived from PET/CT scan imaging.
MRI brain metrics
Time frame: Up to 6 months
Including anatomic assessment based on T1, T2, and contrast enhanced T1 weighted imaging, MR spectroscopy data (choline, creatinine, and N-acetyl acetate peak integrals and ratios), MR perfusion data (relative cerebral blood volume), and diffusion tensor imaging data (apparent diffusion coefficient, fractional anisotropy)
Surgical pathology or 3-6 month interval multidisciplinary clinical evaluation.
Time frame: Up to 6 months
To be compared with the imaging analyses for comparing ability to differentiate tumor recurrence from radiation necrosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- 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.
Bijoy Kundu, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Positron Emission Tomography, Computed Tomography and Multiparametric Magnetic Resonance Imaging Scan in people with Glioblastoma, run by University of Virginia 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 10 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bijoy Kundu, PhD ((434) 924-0284, bkk5a@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative parametric maps indicating differences in rates of glucose and amino acid uptake (Ki) obtained from dynamic FDG and FDOPA scans respectively. (time frame: Up to 6 months). The study lists 5 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 24 Mar 2020.