Recruiting
Early Phase 1

FDG & FDOPA

Sponsor:

University of Virginia

Code:

NCT04315584

Conditions

Glioblastoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positron Emission Tomography

Computed Tomography

Multiparametric Magnetic Resonance Imaging Scan

Fludeoxyglucose F-18

fluorine F 18 fluorodopa

Study Details

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

Study ID

NCT04315584

Start date

Mar 15, 2020

Status verified date

Mar, 2020

Completion date

Jun 20, 2024

Anticipated

Primary completion date

Dec 20, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic

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.

Interventions

Positron Emission Tomography

Undergo PET/CT Scans

Computed Tomography

Undergo PET/CT Scans

Multiparametric Magnetic Resonance Imaging Scan

Undergo a multiparametric MRI scan

Fludeoxyglucose F-18

IV (intravenous) administration of radiotracer

fluorine F 18 fluorodopa

IV (intravenous) administration of radiotracer

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 ]
  • 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 ]
  • 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 ]
  • MRI brain metrics [ Time Frame: Up to 6 months ]
  • Surgical pathology or 3-6 month interval multidisciplinary clinical evaluation. [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Bijoy Kundu, PhD

(434) 924-0284bkk5a@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Florence Yan

434-243-6768fty5jf@hscmail.mcc.virginia.edu

Principal Investigator:

Bijoy Kundu, PhD

More Information

Sponsor

University of Virginia

Last update posted

Mar 24, 2020

Last verified

Mar, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2020-03-24.