Radiopharm Theranostics (NASDAQ:RADX), a developer of a world-class platform of radiopharmaceutical products, today announced it has completed enrollment in its U.S. Phase 2b imaging trial of RAD 101 (18F-FET).
The company successfully dosed the final participant in the 30-patient study, which focuses on the detection and assessment of recurrent brain metastases.
RAD 101 is designed to address a critical diagnostic gap in neuro-oncology: the difficulty in distinguishing between true tumor recurrence and "pseudo-progression" or treatment effects caused by radiation.
The imaging agent has already received FDA Fast Track designation, a status intended to expedite the development of drugs that treat serious conditions and fill unmet medical needs.
Interim data from the trial has been highly encouraging, demonstrating a 90% concordance rate with MRI results.
Unlike standard imaging, RAD 101 targets specific metabolic pathways in cancer cells, potentially offering a more precise look at active disease.
The completion of enrollment keeps the company on track for a primary endpoint readout, which is anticipated in June 2026.
Pending the results of the June readout, Radiopharm intends to engage with the FDA to advance RAD 101 into a U.S. Phase 3 pivotal trial.
If successful, RAD 101 could become a foundational tool in the diagnostic toolkit for brain cancer, helping patients avoid unnecessary surgeries or treatments while ensuring that those with recurrent disease receive timely intervention.