18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Launched by BAPTIST HEALTH SOUTH FLORIDA · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to see how well treatment works for patients with brain cancer that has spread to the brain, known as brain metastases. Specifically, the study is testing a special imaging technique called 18F-Fluciclovine PET to see if it can help doctors measure how well patients respond to a treatment called stereotactic radiosurgery (SRS). This technique is non-invasive and could provide important information about the growth or reduction of brain tumors after treatment.

To participate in this trial, patients need to have a diagnosis of cancer that has spread to the brain, with tumors that are 2 centimeters or smaller. They should be planning to receive SRS treatment and have a good overall health status. Patients will undergo imaging scans to track their progress, and they’ll be monitored closely throughout the study. It's important to note that certain individuals, such as those who have had previous brain radiation or certain medical conditions, may not be eligible. Overall, this study aims to explore a promising tool that could help improve care for patients with brain metastases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of cancer with radiographic finding of brain metastasis
• • Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
• • Planned treatment with SRS as per the treating physician team
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET
• Exclusion Criteria:
• • Prior anaphylactic reaction to 18F-fluciclovine
• • Radiographic evidence of leptomeningeal disease
• • Prior whole-brain radiation therapy
• • Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
• • Pregnant or positive serum pregnancy test within 14 days of registration
• • Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 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 and/or preclude informed consent\*
• • A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.