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Completed

NCT Number: NCT01165632

Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma

RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.

PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma

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Key information

About this study

PRIMARY OBJECTIVES:

I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.

II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.

SECONDARY OBJECTIVES:

I. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.

OUTLINE:

Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.

After completion of study treatment, patients are followed up every year for 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
  • Planned craniotomy and resection or biopsy
  • Willing to sign release of information for any radiation and/or follow-up records
  • Negative pregnancy test done =< 48 hours of injection of study drug, for women of childbearing potential only
  • Provide informed written consent
  • Patients with eGFR < 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient is not eligible to receive the contrast for the pMRI at the study dose.

Exclusion criteria

  • Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
  • Unable to undergo an 18F-FDOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
  • Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception

Treatment and study plan

Biopsy

Procedure

Correlative studies

Other names: biopsies

Computed Tomography

Procedure

Undergo computed tomography

Other names: tomography, computed

therapeutic conventional surgery

Procedure

Undergo stereotactic craniotomy

radiation therapy treatment planning/simulation

Radiation

Undergo radiation therapy treatment planning/simulation

radiation therapy

Radiation

Undergo radiation therapy

Other names: irradiation, radiotherapy, therapy, radiation

Magnetic Resonance Imaging

Procedure

Undergo magnetic resonance imaging

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Positron Emission Tomography

Procedure

Undergo positron emission tomography

Other names: FDG-PET, PET, PET scan, tomography, emission computed

Fluorine F 18 Fluorodopa

Drug

Given IV

Other names: (18)F-FDOPA, 18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPA

Primary outcomes

  1. 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

    Time frame: Up to 2 years

    Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.

  2. 18F- FDOPA-PET metabolic imaging information

    Time frame: Up to 2 years

    Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.

Secondary outcomes

  1. Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

    Time frame: Up to 2 years

    Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.

  2. With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information

    Time frame: 2 Years

    Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning.

  3. 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies

    Time frame: 2 years

    Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors

Important dates

Study start
2010
Primary completion
2013
Study completion
2019
First posted
Jul 20, 2010
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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