18F-DOPA-PET in Planning Surgery in Patients With Gliomas
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Malignant Glioma
- Recurrent Brain Neoplasm
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 7 years and 125 years
- Gender
- Both males and females
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 enhance...
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.
Tracking Information
- NCT #
- NCT02020720
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Nadia Laack Mayo Clinic
Get Well Soon