Actively Recruiting
Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Led by Baptist Health South Florida · Updated on 2026-04-22
20
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age �318 years
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Confirmed brain metastases with at least one untreated lesion larger than 2 cm in maximum diameter
- Scheduled to receive staged stereotactic radiosurgery (SSRS) as planned by the treating team
- For women who can become pregnant, a negative serum pregnancy test within 14 days before joining the study
- Women of reproductive potential must use highly effective contraception for at least 4 weeks before screening and agree to continue during study treatment and for 1 week after post-treatment imaging
You will not qualify if you...
- Previous anaphylactic reaction to 18F-fluciclovine
- Presence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Contraindication to MRI, such as having a pacemaker
- Women who are pregnant at the expected time of imaging
- Women breastfeeding at the time of imaging who are unwilling to stop breastfeeding for 24 hours
- Major medical illness or psychiatric/cognitive conditions that prevent completing the study or giving informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
R
Rupesh C Kotecha, MD
CONTACT
K
Kristy Reyes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here