18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain

Mayo Clinic

Status: Active, not recruiting

Conditions: Metastatic Intracranial Malignant Neoplasm; Recurrent Intracranial Neoplasm

Treatments: Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography; Other: Fluciclovine F18

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04462419

MC1975 (Other Identifier)

NCI-2020-04564 (Registry Identifier)

19-004459 (Other Identifier)

Details and patient eligibility

About

This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). F-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. The results of this study may also help investigators understand all the ways that F-18 fluciclovine may affect patients.

Full description

PRIMARY OBJECTIVE:

I. To determine the static fluciclovine F18 (fluciclovine) PET imaging tumor-to-background ratios (TBRmax; TBRmean) which distinguish true tumor recurrence from radionecrosis in patients with intracranial metastatic disease previously treated with radiation therapy, and magnetic resonance imaging (MRI) findings suggesting recurrent disease, using histopathology as proof of disease.

SECONDARY OBJECTIVES:

I. To determine static fluciclovine PET standardized uptake value (SUV)peak, SUVmean values and metabolic tumor volumes (MTV) which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using serial MRI as a surrogate marker of disease.

II. To determine early dynamic fluciclovine PET time activity curve values which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using histopathology or serial MRI as a marker of disease.

III. To correlate the determined static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival.

IV. In patients with true tumor progression, SUV values will be correlated with Ki67 staining on final pathology.

OUTLINE:

Patients receive fluciclovine intravenously (IV) and undergo brain dynamic PET/MRI imaging over 50 minutes.

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

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical evidence of intracranial metastatic disease which underwent radiation and who presents with MRI findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion')

Exclusion criteria

• Contraindication to contrast enhanced MRI
• Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm)
• Inability to lie still for 50 minutes during fluciclovine PET-MRI imaging
• Inability or refusal to consent
• Allergy or anaphylaxis to any of the reagents used in this study
• Inability or unwillingness to return for required visits and follow-up exams

Trial design

19 participants in 1 patient group

Diagnostic (18F-fluciclovine, PET/MRI imaging)

Description:

Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes.

Treatment:

Other: Fluciclovine F18

Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography