Lutroo Imaging Starts Phase 1 Trial of Radiocaine™ for Pain Imaging

Lutroo Imaging, a company specializing in molecular imaging, has initiated the first Phase 1 clinical trial involving their new PET radiotracer, Radiocaine™. This trial marks the debut of Radiocaine™ in human testing, aiming to transform the diagnosis and treatment of pain by visualizing sodium channels related to pain in peripheral nerves.

Radiocaine™ is designed to address a critical void in pain management by providing a technology capable of visualizing pain, a feature currently missing in medical practice. This innovation is particularly significant given the high number of adults in the United States—more than 50 million—suffering from chronic pain without an effective diagnostic tool. The ongoing opioid crisis further highlights the need for more precise and safe pain treatment options. Radiocaine™ could potentially meet this demand by accurately detecting and measuring pain.

The Phase 1 clinical trial for Radiocaine™ is being held under an FDA Investigational New Drug application. The trial is an open-label study focusing on assessing the safety, distribution of the drug within the body, and radiation dosimetry of Radiocaine™. It utilizes Fluorine-18 labeling to achieve high-resolution PET imaging, targeting voltage-gated sodium channels involved in pain signaling.

Dr. P. David Mozley, the Chief Medical Officer at Lutroo Imaging, emphasized the importance of this development, noting that Radiocaine™ could fundamentally change how pain is detected and understood. By making the previously invisible pain signals visible, clinicians can gain deeper insights into pain conditions.

Dr. Braxton Norwood, CEO of Lutroo Imaging, reinforced this viewpoint, stating that Radiocaine™ could not only localize and quantify pain but also serve as a biomarker in clinical trials to objectively measure the effectiveness of pain therapies.

The Phase 1 trial is a single-center, open-label study enrolling healthy volunteers. Its primary objectives include evaluating the safety profile of Radiocaine™, understanding its dosimetry, and analyzing its biodistribution. The results of this study are expected to guide future research into various pain disorders, such as neuropathic pain and lower back pain.

Radiocaine™ employs PET imaging technology, a well-established method in clinical settings. By leveraging existing PET infrastructure, Radiocaine™ could quickly become integrated into clinical practice, given its potential to offer widespread accessibility in hospitals and academic centers.

Radiocaine™, labeled with Fluorine-18, is crafted to bind with voltage-gated sodium channels in pain-associated peripheral nerves, which are often upregulated in conditions involving pain, such as neuropathic and inflammatory pain, as well as cancer-related and post-surgical pain. Beyond its clinical applications, Radiocaine™ aims to function as a quantitative imaging biomarker in both medical practice and pain research.

It is important to note that Radiocaine™ is an investigational radiopharmaceutical not yet approved by the U.S. Food and Drug Administration for any use outside clinical trials.

Lutroo Imaging, the company behind Radiocaine™, focuses on developing advanced PET radiotracers for various neurological disorders, including pain. Their mission is to enhance the understanding and treatment of human health conditions through precision molecular imaging, making invisible biological processes visible.