Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery

NCT ID: NCT04689048Sponsor: Baptist Health South FloridaLast updated: 2026-04-22

Summary

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Arms & interventions

  • Drug18F fluciclovine

    Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Outcome measures

Primary

  • Change in sensitivity for PET/CT

    Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS.

    Time frame: through study completion, an average of 1 year

  • Change in sensitivity for MRI

    To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

    Time frame: through study completion, an average of 1 year

  • Change in the standardized uptake value (SUV) parameters

    To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.

    Time frame: through study completion, an average of 1 year

Secondary

  • Compare change of SUV metrics of 18F-fluciclovine PET

    Time frame: baseline

  • Compare change of SUV metrics of contrast-enhanced MRI

    Time frame: baseline

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Male or female, age ≥18 years 2. Performance status, Eastern Cooperative Oncology Group 0-2 3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter 4. Plan for SSRS per the treating team 5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required 6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography Exclusion Criteria: 1. Prior anaphylactic reaction to 18F-fluciclovine 2. Evidence of leptomeningeal disease 3. Prior whole-brain radiation therapy 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) 5. Females pregnant at the expected time of 18F-fluciclovine administration 6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed 7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Study locations (1)

Miami Cancer Institute

Miami, Florida, 33176

Recruiting
Rupesh C Kotecha, M.D. · Contact

References

  • Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.(PubMed)