Results of a study led by Baptist Health Miami Cancer Institute presented at ASCO

The results of a multi-institutional clinical trial led by Miami Cancer Institute, a part of Baptist Health, could bring a monumental shift in the management of patients with brain metastases. Rupesh Kotecha, M.D., chief of Radiosurgery and director of Central Nervous System Metastasis at the Institute, presented the findings at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 2.

Dr. Kotecha was the coordinating investigator of the study and first author of “Evaluating the Diagnostic Performance of ¹⁸F-fluciclovine for Detection of Recurrent Brain Metastases After Radiation Therapy: Results from a Prospective Phase 2 Trial.”

The trial looked at the use of ¹⁸F-fluciclovine, a synthetic amino acid-based PET radiopharmaceutical agent, and its uptake in the brain to detect recurrent brain metastases. The ability to differentiate tumor tissue from treatment-related conditions such as radiation necrosis in these patients has historically been a key concern among physician-researchers.

 ¹⁸F-fluciclovine is already approved by the U.S. Food and Drug Administration for PET imaging in men with recurrent prostate cancer and is being investigated for use in diagnosing other cancers. The trial is the first prospective multicenter trial of its kind.

“There have been multiple PET imaging agents and techniques evaluated in the past,” Dr. Kotecha said. “But this is the first time we have been able to evaluate PET characteristics of these metastases after radiation therapy where we had complete confirmation with histopathology.” Patients participating in the study were already slated for craniotomy.

In addition to qualitative measures, quantitative and dynamic metrics were also evaluated. When the imaging evaluation was correlated with the histopathology, “we found that ¹⁸F-fluciclovine is a high-performing diagnostic tool,” Dr. Kotecha said.

The results are significant for potential patient treatment planning. The performance of ¹⁸F-fluciclovine PET may mean that physicians can better identify patients who have disease progression and would benefit from surgery or a change in therapy and prevent an unnecessary surgery for those who have treatment change.

“About one-third of brain metastases that are treated with radiosurgery increase in size in later imaging and this translates to about one-half of our patients being told, at some point, that a treated lesion has increased in size,” Dr. Kotecha said. “This not only creates management dilemmas but is also anxiety-provoking for patients and the treatment team. This has been an area of unmet need with MRI alone.”

The clinical trial also helped Dr. Kotecha and his colleagues develop image interpretation criteria. He is also involved in a Phase 3 study (NCT04410133) to establish the diagnostic performance of ¹⁸F-fluciclovine PET imaging in patients with recurrent brain metastases, which recently completed patient accrual.

The phase 2 trial abstract may be found here.