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

Status: Active

Description

This phase IV trial studies how well 18F-fluciclovine positron emission tomography (PET) / computed tomography (CT) works in diagnosing radiation necrosis versus tumor progression in patients with cancer that has spread to the brain (metastatic) following stereotactic radiosurgery. Radiation necrosis is damage that occurs to normal brain tissue caused by radiation and looks similar to a tumor that is growing, spreading, or getting worse (tumor progression) when viewed using magnetic resonance imaging (MRI). 18F-fluciclovine PET / CT may be able to distinguish radiation necrosis from tumor progression in cases where the MRI is inconclusive.

Eligibility Criteria

Inclusion Criteria

  • Subjects must have a confirmed diagnosis of brain metastases
  • Subjects must have received prior intracranial stereotactic radiosurgery (SRS) at least once for brain metastases. Prior whole brain radiotherapy (WBRT) is allowed
  • Subjects must have had a clinical tumor protocol magnetic resonance imaging (MRI) of the brain including a dynamic susceptibility contrast (DSC)-magnetic resonance (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
  • Physician assessed life expectancy of >= 6 months
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document
  • For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required

Exclusion Criteria

  • Subjects who have experienced a prior anaphylaxis reaction to 18F-fluciclovine are not eligible
  • 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
  • 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
  • Subjects contraindicated for MRI
  • Subjects unable or unwilling to comply with study requirements are not eligible
  • Major medical illness or psychiatric impairments, which in the investigator’s opinion, will prevent completion of protocol therapy and/or preclude informed consent
  • Brain metastases from primary lymphoma, germ cell tumor, or small cell carcinoma

Locations & Contacts

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Contact: Samuel Tay Chao
Phone: 216-445-7876
Email: chaos@ccf.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. The accuracy of fluciclovine F18 (18F-fluciclovine) PET in distinguishing radiation necrosis from tumor progression will be estimated via receiver operating characteristic curve analysis.

SECONDARY OBJECTIVES:

I. To assess which factors may influence accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression.

II. To estimate sensitivity and specificity.

III. To compare the accuracy of each of the qualitative and quantitative metrics of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and then undergo a PET/CT scan over 25 minutes.

After completion of study, patients are followed up every 3 months for 1 year.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Diagnostic

Lead Organization

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Samuel Tay Chao

Trial IDs

Primary ID CASE2319
Secondary IDs NCI-2019-03931
Clinicaltrials.gov ID NCT03930173