NCT02020720

18F-DOPA-PET in Planning Surgery in Patients With Gliomas

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.

Detailed description

PRIMARY OBJECTIVES: I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from 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. Patients then undergo stereotactic craniotomy or image-guided biopsy. After completion of study treatment, patients are followed up yearly for 5 years.

Conditions

• Malignant Glioma
• Recurrent Brain Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo image-guided biopsy
PROCEDURE	Computed Tomography	Undergo 18F-DOPA-PET/CT
PROCEDURE	Diffusion Weighted Imaging	Undergo DTI
DRUG	Fluorine F 18 Fluorodopa	Undergo 18F-DOPA-PET/CT
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Perfusion Magnetic Resonance Imaging	Undergo pMRI
PROCEDURE	Positron Emission Tomography	Undergo 18F-DOPA-PET/CT
PROCEDURE	Therapeutic Conventional Surgery	Undergo stereotactic craniotomy

Timeline

• Start date: 2014-01-22
• Primary completion: 2019-10-25
• Completion: 2024-01-10
• First posted: 2013-12-25
• Last updated: 2025-01-23

Locations

1 site across 1 country: United States