NCT04689048 Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
| NCT ID | NCT04689048 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Baptist Health South Florida |
| Condition | Brain Metastases, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-04-04 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Rupesh R Kotecha, MD
PRINCIPAL INVESTIGATOR
Miami Cancer Institute (MCI) at Baptist Health, Inc.
Frequently Asked Questions
Who can join the NCT04689048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04689048 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04689048 currently recruiting?
Yes, NCT04689048 is actively recruiting participants. Contact the research team at rupeshk@baptisthealth.net for enrollment information.
Where is the NCT04689048 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT04689048 clinical trial?
NCT04689048 is sponsored by Baptist Health South Florida. The principal investigator is Rupesh R Kotecha, MD at Miami Cancer Institute (MCI) at Baptist Health, Inc.. The trial plans to enroll 20 participants.