Lutroo Imaging LLC
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study will enroll six adult volunteers, each of whom will receive a single intravenous dose of Radiocaine™. Serial PET/MR imaging will be performed over several hours post-injection to assess the distribution of the radiotracer in various tissues and organs. Blood and urine samples will be collected at predefined timepoints to support pharmacokinetic and dosi…
Inclusion Criteria: * 18 years and older * Able to provide written consent * Willing and able to undergo ECG, imaging, blood sampling, and complete self-assessment rating scales at the specified time points * Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points Exclusion Criteria: * Body mass index (BMI) of 32 or greater, weight \>300 lbs * Diagnosis of severe depression/anxiety (PROMIS score \> 95%) or suicidal ideation * History of opioid abuse or opioid use disorder * History of seizures or epilepsy * Histor…
Intravenous injection of Radiocaine
Arctuva estimate
Verify or correct the compensation shown for this listing.