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

Launched by BAPTIST HEALTH SOUTH FLORIDA · Dec 28, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging agent called 18F-fluciclovine to see how well it can detect which patients with large brain metastases are responding to a specific type of radiation therapy called staged stereotactic radiosurgery (SSRS). Brain metastases occur when cancer spreads to the brain, and this study aims to understand how these tumors change over time after treatment using this imaging method.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of brain metastases, with at least one untreated tumor that is larger than 2 centimeters. The study is open to both men and women, and women who can become pregnant must have a negative pregnancy test and use effective birth control. Participants can expect to undergo imaging tests with 18F-fluciclovine to monitor their response to treatment. The trial is currently recruiting, and it's important to note that certain individuals, such as those with previous severe reactions to this imaging agent or certain medical conditions, may not be eligible to join.

Gender

ALL

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