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

Not Applicable

Terminated

• Conditions: Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Brain Stem Glioma; Childhood Low-grade Cerebellar Astrocytoma; Childhood Low-grade Cerebral Astrocytoma; Recurrent Adult Brain Tumor; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Stem Glioma
• Interventions: Drug: 18F-fluoro-dihydroxyphenylalanine; Procedure: Positron emission tomography (PET); Procedure: Computed tomography (CT); Procedure: Magnetic resonance imaging

• Registration Number: NCT02175745
• Lead Sponsor: Erik Mittra

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Study Start: 2014-12
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2017-01
• Results First Submitted: 2017-01-30
• Results First Submitted QC: 2017-01-30
• Last Update Submitted: 2017-01-30
• Results First Posted: 2017-03-20
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (FDOPA-PET/CT or PET/MRI)	18F-fluoro-dihydroxyphenylalanine	Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
Diagnostic (FDOPA-PET/CT or PET/MRI)	Computed tomography (CT)	Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
Diagnostic (FDOPA-PET/CT or PET/MRI)	Positron emission tomography (PET)	Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.
Diagnostic (FDOPA-PET/CT or PET/MRI)	Magnetic resonance imaging	Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.

Primary Outcome Measures

Name	Time	Method
Number of Suspicious Lesions Identified by 18F FDOPA PET	Up to 30 minutes after injection of F18 FDOPA	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.
Percent Agreement of 18F FDOPA PET With Pathology	Up to 30 minutes post-injection (at time of scan)	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.

Trial Locations

Locations (1)

Stanford University Hospitals and Clinics; 🇺🇸 Stanford, California, United States