18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas

Erik Mittra2 enrolled

Overview

To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.

This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma

Interventions

18F-fluoro-dihydroxyphenylalanineDRUG

Administered intravenously (IV)

Positron emission tomography (PET)PROCEDURE

Component of an 18F-FDOPA PET/CT or PET/MRI scan

Computed tomography (CT)PROCEDURE

Component of an 18F-FDOPA PET/CT

Magnetic resonance imagingPROCEDURE

Component of an 18F-FDOPA PET/MRI

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Greater than 15 year-old at the time of radiotracer administration * Provides written informed consent * Suspected new diagnosis or suspected recurrence of glioma * Able to remain still for duration of each imaging procedure (about 20 minutes) Exclusion Criteria: * Less than 15 year-old at the time of radiotracer administra * Unable to provide informed consent * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Outcomes

Primary Outcomes

Number of Suspicious Lesions Identified by 18F FDOPA PET

The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.

Time frame: Up to 30 minutes after injection of F18 FDOPA

Percent Agreement of 18F FDOPA PET With Pathology

For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.

Time frame: Up to 30 minutes post-injection (at time of scan)