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

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01165632

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

149.2

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: biopsy Procedure: computed tomography Procedure: therapeutic conventional surgery Radiation: radiation therapy treatment planning/simulation Radiation: radiation therapy Procedure: magnetic resonance imaging Procedure: positron emission tomography Drug: fluorine F 18 fluorodopa	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jul 26, 2010

Actual Primary Completion Date :

Nov 1, 2013

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I 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.	Procedure: biopsy Correlative studies Other Names: biopsies Procedure: computed tomography Undergo computed tomography Other Names: tomography, computed Procedure: therapeutic conventional surgery Undergo stereotactic craniotomy Radiation: radiation therapy treatment planning/simulation Undergo radiation therapy treatment planning/simulation Radiation: radiation therapy Undergo radiation therapy Other Names: irradiation radiotherapy therapy, radiation Procedure: magnetic resonance imaging Undergo magnetic resonance imaging Other Names: MRI NMR imaging NMRI nuclear magnetic resonance imaging Procedure: positron emission tomography Undergo positron emission tomography Other Names: FDG-PET PET PET scan tomography, emission computed Drug: fluorine F 18 fluorodopa Given IV Other Names: (18)F-FDOPA 18F-6- L-fluorodopa 18F-DOPA 18F-FDOPA

Arm

Intervention/Treatment

Experimental: Arm I

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.

Procedure: biopsy

Correlative studies

Other Names:

biopsies

Procedure: computed tomography

Undergo computed tomography

Other Names:

tomography, computed

Procedure: therapeutic conventional surgery

Undergo stereotactic craniotomy

Radiation: radiation therapy treatment planning/simulation

Undergo radiation therapy treatment planning/simulation

Radiation: radiation therapy

Undergo radiation therapy

Other Names:

irradiation

radiotherapy

therapy, radiation

Procedure: magnetic resonance imaging

Undergo magnetic resonance imaging

Other Names:

MRI

NMR imaging

NMRI

nuclear magnetic resonance imaging

Procedure: positron emission tomography

Undergo positron emission tomography

Other Names:

FDG-PET

PET

PET scan

tomography, emission computed

Drug: fluorine F 18 fluorodopa

Given IV

Other Names:

(18)F-FDOPA

18F-6- L-fluorodopa

18F-DOPA

18F-FDOPA

Outcome Measures

Primary Outcome Measures

18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [Up to 2 years]
Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
18F- FDOPA-PET metabolic imaging information [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 Outcome Measures

Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies [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.
With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information [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.
18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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