Status:
RECRUITING
Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Lead Sponsor:
Baptist Health South Florida
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Brain Metastases, Adult
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Male or female, age ≥18 years
- Performance status, Eastern Cooperative Oncology Group 0-2
- Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
- Plan for SSRS per the treating team
- For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
- 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
- Prior anaphylactic reaction to 18F-fluciclovine
- Evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Females pregnant at the expected time of 18F-fluciclovine administration
- 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
- Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04689048
Start Date
April 4 2022
End Date
December 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Miami Cancer Institute
Miami, Florida, United States, 33176