Brain scan with 18F-fluciclovine for large brain metastases after radiation treatment
Tests 18F-fluciclovine imaging in adults with large brain metastases receiving radiosurgery.
Key facts
- Who runs it
- Baptist Health South Florida
- Where
- Miami, United StatesSee the site
- Trial code
- Registry title
- Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 20 people, planned
- Started
- 4 Apr 2022
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- 18F fluciclovine
- Record updated
- 22 April 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 brain metastases (cancer that has spread to the brain) who are planned for staged stereotactic radiosurgery (SSRS), a focused radiation treatment given in steps. It tests whether 18F-fluciclovine PET/CT scans can show who responds.
- Age
- 18 years and older
- Sex
- All sexes can join
- Disease stage
- Confirmed brain metastases with at least one untreated lesion >2 cm (0.8 in) in maximum diameter. Able to care for yourself at least partly (ECOG performance status 0-2). The treating team plans SSRS.
- Earlier treatment
- People who had whole-brain radiation therapy before cannot join.
- Biomarker or test result
- Women who could become pregnant need a negative blood pregnancy test within 14 days of registration.
Main reasons for not taking part
- Past severe allergic reaction (anaphylaxis) to 18F-fluciclovine
- Cancer spread to the lining of the brain and spinal cord (leptomeningeal disease)
- Cannot have an MRI, for example because of a pacemaker
- Pregnant, or breastfeeding and unwilling to stop for 24 hours after the scan
- Major medical illness or mental or thinking problems that would prevent finishing the study or giving consent
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior anaphylactic reaction to 18F-fluciclovine
- Prior whole-brain radiation therapy
- Evidence of leptomeningeal disease
- Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
- 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
Where in United States
- Miami Cancer InstituteMiami, United StatesContact: Rupesh C Kotecha, M.D.Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- PET/CT, MRIOther group
In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.
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
- Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery
- Plain-language title
- Brain scan with 18F-fluciclovine for large brain metastases after radiation treatmentGenerated 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
- 22 April 2026