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

Abstract Background 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, 18F-fluciclovine, to be potentially useful in discriminating brain tumor recurrence from treatment-related changes. This may potentially help physicians to make confident diagnoses and inform subsequent treatment plans. Material and Methods REVELATE (NCT04410133) will evaluate the diagnostic performance of 18F-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 18F-fluciclovine PET <42 days after the equivocal MRI and 1-21 days pre-biopsy/neurosurgical intervention. Clinical follow-up will occur for 6m post-18F-fluciclovine PET. Results The primary endpoint of REVELATE is the subject-level 18F-fluciclovine negative and positive percent agreement (equivalent to specificity and sensitivity, respectively) for detection of recurrent brain metastases. Further objectives include evaluation of the lesion-level diagnostic performance, inter-reader and intra-reader agreement, and safety evaluations. Conclusion This ongoing phase 3 study will provide efficacy and safety data for the use of 18F-fluciclovine for the detection of recurrent brain metastases. Enrolment began in October 2020 and the trial is active but not recruiting at the time of submission.