Overview

This trial is active, not recruiting.

Conditions 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
Treatments biopsy, computed tomography, therapeutic conventional surgery, radiation therapy treatment planning/simulation, radiation therapy, magnetic resonance imaging, positron emission tomography, fluorine f 18 fluorodopa
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date July 2010
End date July 2017
Trial size 30 participants
Trial identifier NCT01165632, 10-001904, MC1078, NCI-2010-01607

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
biopsy biopsies
Correlative studies
computed tomography tomography, computed
Undergo computed tomography
therapeutic conventional surgery
Undergo stereotactic craniotomy
radiation therapy treatment planning/simulation
Undergo radiation therapy treatment planning/simulation
radiation therapy irradiation
Undergo radiation therapy
magnetic resonance imaging MRI
Undergo magnetic resonance imaging
positron emission tomography FDG-PET
Undergo positron emission tomography
fluorine f 18 fluorodopa (18)F-FDOPA
Given IV

Primary Outcomes

Measure
18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
time frame: Up to 2 years
18F- FDOPA-PET metabolic imaging information
time frame: Up to 2 years

Secondary Outcomes

Measure
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
With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information
time frame: 2 Years
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.