Amino acid PET in neuro-oncology: applications in the clinic.
Norbert Galldiks, Karl-Josef Langen
https://pubmed.ncbi.nlm.nih.gov/28277832Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06048094
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
Led by Baptist Health South Florida · Updated on 2026-05-20
46
Participants Needed
1
Research Sites
47 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
Researchers are evaluating the use of 18F-Fluciclovine positron emission tomography (PET) as a biomarker to measure the response or progression of brain metastasis in participants treated with stereotactic radiosurgery (SRS). This pilot imaging study focuses on adults diagnosed with brain metastases who are planned to receive SRS treatment. The study is sponsored by Baptist Health South Florida and is a Phase 1 clinical trial. Participants will undergo an 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). They will then receive a single dose of SRS as part of their standard care. A second 18F-fluciclovine PET scan will be performed approximately 8 weeks after the SRS treatment, with a window of plus or minus 2 weeks. During PET scans, participants receive a 5-mCi dose of 18F-fluciclovine through intravenous injection, with imaging data collected up to 25 minutes post-injection. Throughout the study, participants will be monitored using PET imaging to evaluate changes in standardized uptake values (SUV) over 8 weeks, which helps assess tumor response. Tumor control will also be evaluated at 12 months. The study involves standard imaging, including MRI and PET scans, and tracks participant safety and treatment progress. Total participation timelines include initial scans at SRS planning and follow-up imaging about 8 weeks later, with tumor control assessed after one year.
CONDITIONS
Brief Title
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of cancer with radiographic finding of brain metastasis
- Any number of brain metastasis, with all lesions 2 cm in maximum dimension
- Planned treatment with stereotactic radiosurgery as per the treating physician team
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Individuals of reproductive potential must use two highly effective forms of contraception for at least 4 weeks before screening and during the study until 1 week after the last PET scan
You will not qualify if you...
- Prior anaphylactic reaction to 18F-fluciclovine
- Radiographic evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Inability to undergo MRI (e.g., pacemaker presence)
- Pregnant or positive pregnancy test within 14 days of registration
- Breastfeeding at time of PET and unwilling to stop breastfeeding for 24 hours
- Major medical illness or psychiatric/cognitive impairments preventing protocol completion or informed consent
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Day of SRS planning
Participants undergo a baseline 18F-fluciclovine PET scan at the time of their stereotactic radiosurgery (SRS) planning MRI and receive a 5-mCi dose of 18F-fluciclovine intravenously prior to PET data acquisition.
1 visit (in-person) for baseline PET scan and MRI
Treatment
Duration - Single day
Participants receive single-fraction stereotactic radiosurgery as standard of care for brain metastasis.
1 treatment session
Diagnostic Evaluation
Duration - Approximately 8 weeks after SRS
Participants undergo a second 18F-fluciclovine PET scan approximately 8 weeks (± 2 weeks) after stereotactic radiosurgery to assess changes in brain metastasis.
1 visit (in-person) for follow-up PET scan
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored for tumor control and any long-term outcomes for up to 12 months after stereotactic radiosurgery.
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
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Research Team
R
Rupesh Kotecha, M.D.
K
Kristy Reyes
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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