TheranosticTrials.org

Clinical Trial · NCT03930173

18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis

Overview

The purpose of this study is to evaluate whether 18F-fluciclovine PET/CT of the brain, is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive. 18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.

Sponsor

Case Comprehensive Cancer Center

Phase

Early Phase 1

Contacts

Samuel T Chao, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03930173

Drug / Compound

fluciclovine

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Physician assessed life expectancy of ≥ 6 months.
  • Subjects must have received prior intracranial SRS at least once for brain metastases. Prior WBRT is allowed.
  • For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required.
  • Subjects must have a confirmed diagnosis of brain metastases.
  • Subjects must have had a clinical tumor protocol MRI of the brain including a DSC-MR perfusion sequence, which is equivocal for radiation necrosis versus tumor progression within 30 days of treatment scan. "Equivocal" will be defined as being inconclusive for radiation necrosis versus tumor progression as determined by the study neuroradiologist.

Exclusion

  • Subjects unable or unwilling to comply with study requirements are not eligible.
  • Women who are breast feeding at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the infant from exposure to radiation.
  • Females pregnant at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the fetus from exposure to radiation. Women who could be pregnant require a negative pregnancy test to be eligible.
  • Subjects who have experienced a prior anaphylaxis reaction to 18Ffluciclovine are not eligible.
  • Subjects contraindicated for MRI.