NEIM-03 A MULTICENTER PHASE 3 TRIAL IN PROGRESS: DIAGNOSTIC PERFORMANCE OF(18)F-FLUCICLOVINE PET FOR THE DETECTION OF RECURRENT BRAIN METASTASES AFTER RADIATION THERAPY (REVELATE)

INTRODUCTION: Following treatment of brain metastases, which can affect up to 40% of patients with cancer, patients will typically be closely monitored with serial brain magnetic resonance imaging (MRI) owing to the high likelihood of recurrence. The recommended follow-up modalities (CE-T1-weighted and FLAIR/T2-weighted MRI) have poor specificity, meaning that differentiation of true disease from treatment-related changes such as radiation necrosis can be difficult. Recent pilot studies have reported amino acid PET radiopharmaceutical, (18)F-fluciclovine, to be potentially useful in discriminating tumor recurrence from treatment-related changes. This may potentially aid physicians in making confident diagnoses and inform subsequent treatment plans. METHODS: REVELATE (NCT04410133) will evaluate the diagnostic performance of (18)F-fluciclovine PET (read with conventional MRI for anatomical reference) for the detection of recurrent brain metastases in patients for whom MRI is equivocal. This multicenter, phase 3, prospective, open-label trial aims to enroll approximately 150 subjects from across 19 US sites with solid tumor brain metastases who have undergone radiation therapy, if they have a lesion considered equivocal on MRI that requires further confirmatory diagnostic procedures (either biopsy/neurosurgical intervention or clinical follow-up). Patients will undergo (18)F-fluciclovine PET <42 days after the equivocal MRI and 1–21 days pre-biopsy/neurosurgical intervention. Clinical follow-up will occur for 6m post-(18)F-fluciclovine PET. Secondary objectives include evaluation of subject- and lesion-level (18)F-fluciclovine negative and positive percent agreement (equivalent to specificity and sensitivity, respectively) for recurrent brain metastases, inter-reader and intra-reader agreement, and safety evaluations. Enrolment began in October 2020 and the trial is active but not recruiting at the time of submission.