Status:
COMPLETED
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
Lead Sponsor:
Mayo Clinic
Conditions:
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 clini...
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 delineatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 26 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01165632
Start Date
July 26 2010
End Date
July 26 2019
Last Update
September 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905