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FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Positron Emission Tomography
Computed Tomography
Multiparametric Magnetic Resonance Imaging Scan
Fludeoxyglucose F-18
fluorine F 18 fluorodopa
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma focused on measuring glioblastoma, PET, CT, multiparametric MRI, brain imaging, tumor recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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:

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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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)
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.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2020
Last Updated
March 20, 2020
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04315584
Brief Title
FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
Official Title
FDG and FDOPA PET Demonstration of Functional Brain Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2020 (Anticipated)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
glioblastoma, PET, CT, multiparametric MRI, brain imaging, tumor recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
All 5 study subjects will undergo the same procedures.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
PET, PET Scan, Positron Emission Tomography Scan, Medical Imaging, Positron Emission Tomography
Intervention Description
Undergo PET/CT Scans
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CT, CT Scan, Computerized Axial Tomography, CAT, CAT scan
Intervention Description
Undergo PET/CT Scans
Intervention Type
Procedure
Intervention Name(s)
Multiparametric Magnetic Resonance Imaging Scan
Other Intervention Name(s)
mpMRI, multiparametric MRI
Intervention Description
Undergo a multiparametric MRI scan
Intervention Type
Radiation
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
FDG, 18 FDG, fludeoxyglucose F 18, 2-F18-fluoro-2-deoxy-D-glucose, 2-F18-fluoro-2-deoxyglucose
Intervention Description
IV (intravenous) administration of radiotracer
Intervention Type
Radiation
Intervention Name(s)
fluorine F 18 fluorodopa
Other Intervention Name(s)
18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPA, 3,4-dihydroxy-6-(18)F-fluoro-l-phenylalanine, L-6-[ 18F]fluoro-3, 4-dihydroxyphenylalanine, (18)F-FDOPA
Intervention Description
IV (intravenous) administration of radiotracer
Primary Outcome Measure Information:
Title
Quantitative parametric maps indicating differences in rates of glucose and amino acid uptake (Ki) obtained from dynamic FDG and FDOPA scans respectively.
Description
Will be derived from PET/CT scan imaging.
Time Frame
Up to 6 months
Title
Quantitative parametric maps indicating differences in details (d) components of the wavelet transform analysis, d6 and d8, based on established tumor feature criterions.
Description
Will be derived from MRI brain scan imaging.
Time Frame
Up to 6 months
Title
Semi-quantitative standardize uptake value (SUV) parametric maps based on static PET scans (last 20 minutes of the dynamic PET scans).
Description
Will be derived from PET/CT scan imaging.
Time Frame
Up to 6 months
Title
MRI brain metrics
Description
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)
Time Frame
Up to 6 months
Title
Surgical pathology or 3-6 month interval multidisciplinary clinical evaluation.
Description
To be compared with the imaging analyses for comparing ability to differentiate tumor recurrence from radiation necrosis.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: - 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bijoy Kundu, PhD
Phone
(434) 924-0284
Email
bkk5a@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijoy Kundu, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Yan
Phone
434-243-6768
Email
fty5jf@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Bijoy Kundu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

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