FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

NCT04315584 | Unknown Early Phase 1

• 1 other identifier: HSR190096
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

glioblastoma; PET; CT; multiparametric MRI; brain imaging; tumor recurrence

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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)

  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.

  Up to 6 months

Study Arms (1)

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.

Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Multiparametric Magnetic Resonance Imaging Scan; Radiation: Fludeoxyglucose F-18; Radiation: fluorine F 18 fluorodopa

Interventions

Positron Emission Tomography PROCEDURE

Undergo PET/CT Scans

Also known as: PET, PET Scan, Positron Emission Tomography Scan, Medical Imaging, Positron Emission Tomography

Diagnostic

Computed Tomography PROCEDURE

Undergo PET/CT Scans

Also known as: CT, CT Scan, Computerized Axial Tomography, CAT, CAT scan

Diagnostic

Multiparametric Magnetic Resonance Imaging Scan PROCEDURE

Undergo a multiparametric MRI scan

Also known as: mpMRI, multiparametric MRI

Diagnostic

Fludeoxyglucose F-18 RADIATION

IV (intravenous) administration of radiotracer

Also known as: FDG, 18 FDG, fludeoxyglucose F 18, 2-F18-fluoro-2-deoxy-D-glucose, 2-F18-fluoro-2-deoxyglucose

Diagnostic

fluorine F 18 fluorodopa RADIATION

IV (intravenous) administration of radiotracer

Also known as: 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

Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18; fluorodopa F 18

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Bijoy Kundu, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bijoy Kundu, PhD

CONTACT

(434) 924-0284; bkk5a@virginia.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bijoy Kundu, PhD

Model Details: All 5 study subjects will undergo the same procedures.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: March 15, 2020
• Primary Completion: December 20, 2023
• Study Completion: June 20, 2024
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)