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



Status:Active, not recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:July 26, 2010
End Date:July 2019

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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

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

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.

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
We found this trial at
1
site
Rochester, Minnesota 55905
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mi
from
Rochester, MN
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