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The radiopharmaceutical is already approved for use in PET imaging in men with suspected prostate cancer recurrence.
Blue Earth Diagnostics has completed patient enrollment in its phase 3 REVELATE clinical trial (NCT04410133), which is evaluating the diagnostic performance of 18F-fluciclovine PET (Axumin, Blue Earth Diagnostics) for detecting recurrent brain metastases.
The prospective, multicenter, single-arm study has a target enrollment of 150 adult participants with a history of brain metastases who have undergone prior radiation therapy of those lesions.
Delivered via intravenous bolus, 18F-fluciclovine PET helps visualize the increased amino transport associated with malignancies and consists of a synthetic amino acid that is labeled with radioisotope 18F for PET imaging.
The primary end point of the REVELATE trial is the assessment of the Negative Percent Agreement (NPA, equivalent to specificity) and Positive Percent Agreement (PPA, equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a patient level. In addition, secondary end points will evaluate Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 18F-fluciclovine PET for detecting recurrent brain metastases.
"Recommendations from the Response Assessment in Neuro-Oncology/PET working group in 2019 cite the potential utility of amino acid PET radiopharmaceuticals in distinguishing brain tissue changes after radiation therapy from recurrent brain metastases," said Eugene J. Teoh, MBBS, MRCP, FRCR, DPhil, chief medical officer of Blue Earth Diagnostics, in a statement. "In noting that existing data have been derived mainly from single center, retrospective studies, a call for prospective multi-center studies has been re-iterated to validate these observations."
In addition to REVELATE, Blue Earth has also launched the phase 2b PURSUE clinical trial (NCT04410367) to help establish image interpretation criteria for 18F-fluciclovine PET in recurrent brain metastases. The study will evaluate the sensitivity and specificity of different thresholds of the tracer's uptake on visual reads.
18F-fluciclovine PET was originally FDA-approved on May 27, 2016 for use in patients with recurrent prostate cancer.