Lutroo Imaging has officially launched a Phase 1 clinical trial of Radiocaine™, a first-of-its-kind PET radiotracer designed to make pain visible in the human body. The study marks the first time this novel imaging agent is being tested in human subjects.
Radiocaine™ was developed to address a massive unmet need: over 50 million adults in the U.S. live with chronic pain, yet clinicians still have no tools to objectively visualize it. Using PET imaging—a well-established, widely available technology—Radiocaine™ aims to localize and quantify pain by targeting sodium channels that play a key role in pain signaling.
The trial is being conducted under FDA IND clearance and focuses on evaluating safety, biodistribution, and radiation dosimetry in healthy volunteers. Early preclinical data has shown promising results, including strong signal-to-noise ratios and high selectivity for pain-associated targets.
“There’s a critical need to move beyond guesswork in diagnosing pain,” said Dr. Braxton Norwood, CEO of Lutroo Imaging. “Radiocaine™ has the potential to not only localize and quantify pain, but also to act as a biomarker in clinical trials, helping us measure whether therapies are working, objectively.”
Radiocaine™ is also being positioned as a potential biomarker for use in drug development and clinical trials, helping researchers assess whether new pain therapies are actually working—objectively and in real time.
The trial launch reflects a broader effort to bring precision diagnostics into pain medicine, moving beyond guesswork and trial-and-error prescribing. As the opioid crisis continues to expose the limitations of current treatment approaches, tools like Radiocaine™ could offer a new path forward.
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