TerminatedNot Applicable

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

Stopped: slow enrollment

United States19 participantsStarted 2020-08-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tumor-to-background ratios (TBR)max and TBRmean thresholds

Timeframe: Up to 4 weeks post study registration

Trial details

NCT IDNCT04462419

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-13