Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

PRIMARY OBJECTIVES: I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) for low grade gliomas (LGG). SECONDARY OBJECTIVES: I. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies. II. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients. III. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning. IV. Assess the time to progression for patients receiving resections and biopsies only. TERTIARY OBJECTIVES: I. Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease. II. Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent. III. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning. OUTLINE: Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline and 3 days after resection. Patients then undergo stereotactic craniotomy or image-guided biopsy. After completion of study treatment, patients are followed up yearly for 5 years.

Who is eligible to participate?

Inclusion Criteria: - MRI findings compatible with newly diagnosed or recurrent 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 - Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent - Ability to provide tissue for mandatory correlative research component - Patients with estimated glomerular filtration rate (eGFR) >= 60 mg/min/1.72m^2 Exclusion Criteria: - Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) - Unable to undergo an 18F-DOPA 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) - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception

Last updated:

9/12/2014

NCT ID:

NCT02020720

IRB Number:

13-005102