Using 18F-Fluciclovine to Monitor Brain Metastases After Radiation Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.