TheranosticTrials.org

Clinical Trial · NCT02371031

FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas

Overview

This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving surgical planning and providing non-invasive prognostic information in patients with gliomas that have substantial non-enhancing regions. The results will be used to develop larger adequately powered studies.

Sponsor

Washington University School of Medicine

Phase

Phase 1

Contacts

Tammie Benzinger, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02371031

Drug / Compound

Fluorodopa

Isotope(s):
Target(s):
  • AADC
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Karnofsky performance of \> 50 corresponding to ECOG categories 0, 1, or 2. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Known or suspected diagnosis of intracranial glioma with substantial non-enhancing regions as assessed by contrast enhanced MRI. For the purposes of this study, gliomas with substantial non-enhancing regions are defined as having contrast-enhancing volumes of less than 50% of the total estimated tumor volume. Gliomas that do not have any contrast-enhancing regions are eligible for this study.
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2
  • Standard of care surgical resection and/or stereotactic biopsy of the brain tumor planned within 2 weeks of the FDOPA-PET/MRI study.
  • Measurable disease on MRI defined as tumor measuring at least 1 cm in two perpendicular dimensions.

Exclusion

  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test no more than 3 days prior to FDOPA injection.
  • Patients undergoing PET/MRI: contraindication to gadolinium contrast enhanced brain MRI (i.e., allergy to gadolinium contrast, MRI-incompatible implantable devices, GFR \< 30 mL/min/1.73, and severe claustrophobia). At the discretion of the responsible physician, FDOPA-PET/CT may be performed if PET/MRI is contraindicated or unavailable. If FDOPA-PET/CT is performed, the patient must have undergone a contrast-enhanced MRI for fusion with FDOPA-PET no more than 4 weeks before the FDOPA-PET/CT.
  • Prior chemotherapy or radiation therapy for the brain tumor. Prior biopsy or surgical resection of the glioma without additional therapy is not an exclusion criterion.