Brain scan with 18F-Fluciclovine after radiosurgery for brain metastases
Tests 18F-Fluciclovine PET scans to track brain metastases after radiosurgery in adults.
Key facts
- Who runs it
- Baptist Health South Florida
- Where
- Miami, United StatesSee the site
- Trial code
- Registry title
- 18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 46 people, planned
- Started
- 11 Apr 2024
- Expected to end
- May 2033
- Type of study
- Interventional
- Treatments tested
- 18F fluciclovine
- Record updated
- 20 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cancer that has spread to the brain, who are planned to have stereotactic radiosurgery (SRS, a focused high-dose radiation). It tests whether 18F-Fluciclovine PET scans can show how the brain tumours respond.
- Age
- 18 Years and older
- Sex
- All
- Disease stage
- Brain metastases (cancer spread to the brain) seen on scans. Any number of spots, but each must be ≤ 2 cm (0.8 in) at its widest. ECOG performance status 0-2 (able to care for yourself at least).
- Earlier treatment
- SRS must be planned by the treating doctors. People who had whole-brain radiation therapy before cannot join.
Main reasons for not taking part
- Past severe allergic reaction (anaphylaxis) to 18F-fluciclovine
- Cancer spread to the lining of the brain (leptomeningeal disease) on scans
- Unable to have an MRI, for example because of a pacemaker
- Pregnant, or a positive blood pregnancy test within 14 days of registration
- Breastfeeding and not willing to stop for 24 hours after the scan
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 SRS as per the treating physician team
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET
Who cannot take part
- Prior anaphylactic reaction to 18F-fluciclovine
- Prior whole-brain radiation therapy
- Radiographic evidence of leptomeningeal disease
- Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent*; A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol
- Pregnant or positive serum pregnancy test within 14 days of registration
- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed
Where in United States
- Miami Cancer InstituteMiami, United StatesContact: Rupesh Kotecha, M.D.Taking people
About the trial
What the trial wants to find out
This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.
The group in the trial
- 18F-Fluciclovine PET ImagingTreatment being tested
Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.
Treatment: 18F fluciclovine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
- Plain-language title
- Brain scan with 18F-Fluciclovine after radiosurgery for brain metastasesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 20 May 2026