Clinical trial NCT01165632: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
timeFrame: Up to 2 years
measure: 18F- FDOPA-PET metabolic imaging information
timeFrame: 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
timeFrame: Up to 2 years
measure: With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information
timeFrame: 2 Years
measure: 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nadia N. Laack, M.D.
role: STUDY_CHAIR
References: