Trial: Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (REVELATE)
Recruitment Status: Active, not recruiting
Description: An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy.
Intervention Model: Single Group Assignment
ClinicalTrials.gov Indentifier: NCT04410133
Patient accrual has been completed for the phase 3 REVELATE clinical trial (NCT04410133) investigating potential use of 18F-fluciclovine in detecting recurrent brain metastases after radiotherapy, according to Blue Earth Diagnostics.1
18F-fluciclovine is a PET imaging radiopharmaceutical currently approved for use in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
“Expanding our 18F-fluciclovine franchise into neuro-oncology is part of the overall growth strategy for Blue Earth Diagnostics, and completion of phase 3 patient accrual sets a major milestone in our development plan,” David E. Gauden, DPhil, chief executive officer, stated in the press release. “We look forward to receiving the clinical results from REVELATE, and to presenting results of the phase 2 PURSUE study at upcoming scientific meetings later this year.”
REVELATE is an open-label, single dose, single arm, prospective, multicenter phase 3 study looking to establish the diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases after radiation therapy.2 Patients enrolled will be administered a single intravenous administration of 18F-fluciclovine for PET scan.
“Additionally, we wish to thank the patients, physicians and clinical trial sites who worked closely with us to complete enrollment despite the many challenges presented by the COVID-19 pandemic. In line with our mission to develop novel PET radiopharmaceuticals to inform the management and care of patients with cancer, we are hopeful that our efforts may help patients with recurrent metastatic brain cancer,” Gauden continued in the statement.
To be included in the trial, patients must be aged 18 years and older with an ECOG performance status of 0, 1, or 2, a previous history of solid tumor brain metastasis of any origin, and histopathological confirmation of the primary solid tumor or a metastatic site within 4 years.
Participants must also have had previous radiation therapy of at least 1 brain metastatic lesion, a reference lesion considered to be equivocal for recurrent brain metastasis, and further confirmatory diagnostic procedures to confirm brain MRI findings. Patients with a history of active hematological malignancy will be excluded from the trial.
Primary end points of the trial include positive percent agreement of 18F-fluciclovine PET in detecting recurrent brain metastases and negative percent agreement of 18F-fluciclovine PET in detecting recurrent brain metastases. Secondary end points consist of the positive and negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases, and treatment-emergent adverse events (TEAEs).
“Significant progress has been made in diagnostic imaging modalities to assist in differentiating these entities, among them the use of amino acid-based PET radiopharmaceuticals. The phase 3 REVELATE trial is designed to investigate the diagnostic performance of amino acid 18F-fluciclovine PET imaging as a potential decision-making aid in assessing the status of a patient’s disease,” Samuel T. Chao, MD, from the Department of Radiation Oncology, Cleveland Clinic, professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and coordinating investigator on the REVELATE phase 3 study, said in the press release.
The open-label, single-arm, single-dose, prospective, multicenter, phase 2b PURSUE trial (NCT04410367) is also currently looking to establish image interpretation criteria for 18F-Fluciclovine PET in this patient population.3
Twenty-three patients aged 18 years and older with a history of solid tumor brain metastasis of any origin and a histopathological confirmation of the primary solid tumor or a metastatic site are enrolled in the trial. Enrollment is also open to participants with an ECOG status of 0 to 2, previous radiation therapy of brain metastatic lesions, a reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis, and further confirmatory diagnostic procedures to confirm brain MRI findings.
Sensitivity of different thresholds of lesion 18F-fluciclovine uptake on visual reads and specificity of different thresholds of lesion 18F-fluciclovine uptake on visual reads are primary end points of the trial with secondary outcome measures including TEAEs.
“18F-fluciclovine holds potential clinical utility for the detection of other cancers besides recurrent prostate cancer. As an amino acid-based PET radiopharmaceutical, 18F-fluciclovine is designed to visualize the increased amino acid transport that occurs in malignant tumors and we eagerly await the results of the REVELATE and PURSUE clinical trials,” added Eugene J. Teoh, MBBS, MRCP, FRCR, DPhil, chief medical officer of Blue Earth Diagnostics, in the press release.
Blue earth diagnostics completes patient accrual in phase 3 REVELATE clinical trial of 18F-Fluciclovine PET imaging for detection of recurrent brain metastases. News release. Blue Earth Diagnostics. Published June 08, 2022. Accessed June 9, 2022. https://yhoo.it/3NI3KCP
Study to establish the diagnostic performance of 18F fluciclovine PET in detecting recurrent brain metastases (REVELATE). ClinicalTrials.gov. Accessed June 9, 2022. https://bit.ly/3He79XzStudy to establish image interpretation criteria for 18F fluciclovine PET in detecting recurrent brain metastases (PURSUE). ClinicalTrials.gov. Accessed June 9, 2022. https://bit.ly/3xCHwfV