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

Trial Information

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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Up to 2 years

Safety Issue:

Principal Investigator

Nadia N. Laack, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

MC1078

NCT ID:

NCT01165632

Start Date:

July 2010

Completion Date:

Related Keywords:

Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Diffuse Astrocytoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Myxopapillary Ependymoma
Adult Oligodendroglioma
Adult Pilocytic Astrocytoma
Adult Pineal Gland Astrocytoma
Adult Subependymal Giant Cell Astrocytoma
Adult Subependymoma
Astrocytoma
Ependymoma
Glioblastoma
Glioma
Oligodendroglioma
Glioma, Subependymal
Gliosarcoma

Name	Location
Mayo Clinic	Rochester, Minnesota 55905

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