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FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

NCT04315584 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-03-24

No results posted yet for this study

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

Interventions

PROCEDURE

Positron Emission Tomography

Undergo PET/CT Scans

PROCEDURE

Computed Tomography

Undergo PET/CT Scans

PROCEDURE

Multiparametric Magnetic Resonance Imaging Scan

Undergo a multiparametric MRI scan

RADIATION

Fludeoxyglucose F-18

IV (intravenous) administration of radiotracer

RADIATION

fluorine F 18 fluorodopa

IV (intravenous) administration of radiotracer

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Bijoy Kundu, PhD · University of Virginia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-15
Primary Completion
2023-12-20
Completion
2024-06-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315584 on ClinicalTrials.gov