Using 18F-Fluciclovine to Monitor Brain Metastases After Radiation Therapy
Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery
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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baptist Health South Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT04689048 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a new imaging agent, 18F-fluciclovine, in detecting responses to radiation therapy in patients with large brain metastases. The study aims to assess how well this imaging agent can visualize changes in untreated brain lesions over time following staged stereotactic radiosurgery. Participants will undergo imaging to evaluate the progression or response of their brain metastases, providing valuable insights into treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed brain metastases and at least one untreated lesion larger than 2 cm.
Not a fit: Patients with prior whole-brain radiation therapy or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the monitoring of treatment responses in patients with brain metastases, leading to better personalized treatment strategies.
How similar studies have performed: Other studies using advanced imaging techniques for monitoring brain metastases have shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, age ≥18 years 2. Performance status, Eastern Cooperative Oncology Group 0-2 3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter 4. Plan for SSRS per the treating team 5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required 6. 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 Exclusion Criteria: 1. Prior anaphylactic reaction to 18F-fluciclovine 2. Evidence of leptomeningeal disease 3. Prior whole-brain radiation therapy 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) 5. Females pregnant at the expected time of 18F-fluciclovine administration 6. 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 7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
Where this trial is running
Miami, Florida
- Miami Cancer Institute — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Rupesh R Kotecha, MD — Miami Cancer Institute (MCI) at Baptist Health, Inc.
- Study coordinator: Rupesh C Kotecha, MD
- Email: rupeshk@baptisthealth.net
- Phone: 17865962000
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.