Actively Recruiting
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Led by Baptist Health South Florida · Updated on 2025-12-01
20
Participants Needed
1
Research Sites
364 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
This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.
CONDITIONS
Official Title
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
- Radiographic diagnosis of brain metastasis
- Planned surgical removal of at least one brain metastasis
- Planned postoperative stereotactic radiosurgery (SRS)
- For males or females who can have children, agreement to use two effective contraception methods for at least 4 weeks before screening, during the study, and 1 week after post-treatment PET/CT
- Postmenopausal status defined by absence of menstruation for 1 year or more after stopping hormone treatments, or relevant hormone levels, or surgical sterilization as specified
You will not qualify if you...
- Previous severe allergic reaction to 18F-Fluciclovine
- Presence of leptomeningeal disease
- Previous whole-brain radiation therapy
- Contraindications to MRI such as having a pacemaker
- Pregnant at the expected time of 18F-Fluciclovine injection
- Breastfeeding at the time of 18F-Fluciclovine injection and unwilling to stop breastfeeding for 24 hours after imaging
AI-Screening
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Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
R
Rupesh R Kotecha, M.D.
CONTACT
A
Antoinette Pimentel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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