Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

Recruiting now · Phase 1

Conditions studied: Brain Metastases, Adult, Brain Metastases, Brain Cancer

In brief

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.

Key facts

Study ID

NCT04689048

Run by

Baptist Health South Florida

People needed

20

Starts

2022-04-04

Expected to finish

2027-12-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥18 years
• Performance status, Eastern Cooperative Oncology Group 0-2
• Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
• Plan for SSRS per the treating team
• For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
• 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

You may not qualify if…

• Prior anaphylactic reaction to 18F-fluciclovine
• Evidence of leptomeningeal disease
• Prior whole-brain radiation therapy
• Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
• Females pregnant at the expected time of 18F-fluciclovine administration
• 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
• 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 is running

• Miami Cancer Institute — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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