Evaluating brain metastasis treatment using PET imaging
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
PHASE1 · Baptist Health South Florida · NCT06048094
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baptist Health South Florida (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06048094 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with a diagnosis of cancer and radiographic evidence of brain metastasis, who are scheduled to receive stereotactic radiosurgery.
Not a fit: Patients with prior whole-brain radiation therapy or those with leptomeningeal disease may not benefit from this study.
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 performed: While this approach is innovative, similar studies using PET imaging for treatment evaluation have shown promise, indicating potential for success.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, Brain Metastases, Adult, Brain Cancer, stereotactic radiosurgery, 18F-flucicloivine, PET imaging