Evaluating brain metastasis treatment using PET imaging
Official title: 18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
Run by Baptist Health South Florida · NCT06048094 · Data updated 2026-11-12
This study is testing if a special type of brain scan can help doctors see how well treatment is working for patients with brain tumors caused by cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Baptist Health South Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | April 11, 2024 |
| Main results expected | June 2032 |
| Study ends | May 2033 |
| Registry record updated | May 20, 2026 |
| Trial ID | NCT06048094 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with a diagnosis of cancer and radiographic evidence of brain metastasis, who are scheduled to receive stereotactic radiosurgery.
✕Probably not a fit
Patients with prior whole-brain radiation therapy or those with leptomeningeal disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot imaging study focuses on patients diagnosed with brain metastases who are undergoing treatment with stereotactic radiosurgery (SRS). The study aims to determine if 18F-Fluciclovine positron emission tomography (PET) can serve as a reliable biomarker for assessing the response or progression of brain metastases following SRS. Participants will receive 18F-Fluciclovine and undergo PET imaging to evaluate the effectiveness of their treatment. The study will include patients with various types of cancer that have spread to the brain.
Why it matters
Potential benefit: If successful, this study could provide a new method for monitoring treatment response in patients with brain metastases.
How similar studies have gone: While this approach is innovative, similar studies using PET imaging for treatment evaluation have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior anaphylactic reaction to 18F-fluciclovine * Radiographic evidence of leptomeningeal disease * Prior whole-brain radiation therapy * Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker) * Pregnant or positive serum pregnancy test within 14 days of registration * 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. * 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.
Where it's running
-
Miami Cancer Institute
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Rupesh Kotecha, M.D. — Miami Cancer Institute at Baptist Health, Inc.
- Study coordinator: Rupesh Kotecha, M.D.
- Email: RupeshK@baptisthealth.net
- Phone: (786) 596-2000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using 18F-Fluciclovine to Monitor Brain Metastases After Radiation Therapy
This study is testing a new imaging agent called 18F-fluciclovine to see if it can help track how well radiation therapy is working for people with large brain metastases.
-
Combining TIL Therapy and Pembrolizumab for Advanced Brain Cancer
This study is testing a new treatment that combines a type of immune therapy using patients' own tumor cells with Pembrolizumab to see if it helps people with advanced brain cancer feel better and live longer.
-
Using ex vivo pharmacoscopy to guide treatment for brain metastases
This project will test whether pharmacoscopy, a lab test that screens a patient's tumor cells against many drugs, can help pick effective treatments for adults having surgery for brain metastases.
-
New MRI technique to assess brain tumors after treatment
This study is testing a new MRI method to see if it can tell the difference between real tumor growth and changes caused by treatment in people with brain tumors.
-
Using a special imaging agent to evaluate brain metastases after surgery
This study is testing a special imaging agent to see if it can help doctors find leftover brain tumors after surgery and improve care for patients with brain cancer.
-
Stereotactic radiosurgery for lung cancer that has spread to the brain
This study is testing if a targeted radiation treatment can help people with small cell lung cancer that has spread to their brain feel better and improve their outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.