P15.10.B A multicenter phase 3 trial in progress: diagnostic performance of18F-fluciclovine PET for the detection of recurrent brain metastases after radiation therapy (REVELATE)

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