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

Mayo Clinic

Status and phase

Completed

Early Phase 1

Conditions

Adult Pilocytic Astrocytoma

Adult Anaplastic Ependymoma

Adult Brain Stem Glioma

Adult Diffuse Astrocytoma

Adult Glioblastoma

Adult Anaplastic Astrocytoma

Adult Pineal Gland Astrocytoma

Adult Giant Cell Glioblastoma

Adult Mixed Glioma

Adult Ependymoma

Adult Subependymoma

Adult Oligodendroglioma

Adult Anaplastic Oligodendroglioma

Adult Myxopapillary Ependymoma

Adult Subependymal Giant Cell Astrocytoma

Adult Gliosarcoma

Treatments

Procedure: biopsy

Procedure: therapeutic conventional surgery

Drug: fluorine F 18 fluorodopa

Procedure: positron emission tomography

Procedure: computed tomography

Radiation: radiation therapy

Radiation: radiation therapy treatment planning/simulation

Procedure: magnetic resonance imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01165632

MC1078 (Other Identifier)

NCI-2010-01607 (Registry Identifier)

10-001904 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Arm I

Experimental group

Description:

Beginning at no more than 1 week before biopsy or 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.

Treatment: