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

January 30, 2017 updated by: Erik Mittra

18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (FDOPA-PET/CT or PET/MRI)
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.
Drug: 18F-fluoro-dihydroxyphenylalanine
Administered intravenously (IV)
Other Names:
  • 18F-DOPA
  • 18F-FDOPA
  • (18)F-FDOPA
  • 18F-6-L-fluorodopa
  • Fluorine F-18 fluorodopa
Procedure: Positron emission tomography (PET)
Component of an 18F-FDOPA PET/CT or PET/MRI scan
Other Names:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Procedure: Computed tomography (CT)
Component of an 18F-FDOPA PET/CT
Other Names:
  • tomography, computed
  • CT scan
Procedure: Magnetic resonance imaging
Component of an 18F-FDOPA PET/MRI
Other Names:
  • NMRI
  • nuclear magnetic resonance imaging
  • NMR imaging
  • MRI scan

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erik Mittra

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Erik Mittra, MD, PhD, Stanford University Hospitals and Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-29364
  • P30CA124435 (U.S. NIH Grant/Contract)
  • NCI-2014-01289 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • BRN0024 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Untreated Childhood Brain Stem Glioma

Clinical Trials on 18F-fluoro-dihydroxyphenylalanine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe