Pd22-12 a Phase-1 Trial of Real-Time Intraoperative Fluorescent Imaging of Nerve Structures Using Illuminare-1, a Novel Myelin Binding Fluorophore

You have accessJournal of UrologySurgical Technology & Simulation: Instrumentation & Technology I (PD22)1 May 2024PD22-12 A PHASE-1 TRIAL OF REAL-TIME INTRAOPERATIVE FLUORESCENT IMAGING OF NERVE STRUCTURES USING ILLUMINARE-1, A NOVEL MYELIN BINDING FLUOROPHORE Maria M. Pere, Alex D. Doudt, Trey D. Durdin, Andrew W. Silagy, Luke W. Dean, Pedro Recabal, Erica Levine, Ouathek Ouerfelli, Vanessa Thompson, Alan Burke, Melissa McCarter, Christian Hernandez, Andrew J. Vickers, Peter T. Scardino, Jonathan A. Coleman, James A. Eastham, Vincent P. Laudone, and Timothy F. Donahue Maria M. PereMaria M. Pere , Alex D. DoudtAlex D. Doudt , Trey D. DurdinTrey D. Durdin , Andrew W. SilagyAndrew W. Silagy , Luke W. DeanLuke W. Dean , Pedro RecabalPedro Recabal , Erica LevineErica Levine , Ouathek OuerfelliOuathek Ouerfelli , Vanessa ThompsonVanessa Thompson , Alan BurkeAlan Burke , Melissa McCarterMelissa McCarter , Christian HernandezChristian Hernandez , Andrew J. VickersAndrew J. Vickers , Peter T. ScardinoPeter T. Scardino , Jonathan A. ColemanJonathan A. Coleman , James A. EasthamJames A. Eastham , Vincent P. LaudoneVincent P. Laudone , and Timothy F. DonahueTimothy F. Donahue View All Author Informationhttps://doi.org/10.1097/01.JU.0001009504.18450.e0.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Iatrogenic nerve injury is a leading cause of morbidity associated with many common surgical procedures. Currently, nerve-sparing techniques rely on anatomical landmark identification. There are no approved intra-operative agents to aid in the visualization of nerves. We aim to fill this unmet clinical need through a Phase-I trial using a novel fluorescent, myelin-binding agent to perform real-time intra-operative identification of nerves. METHODS: This is a single-arm, open-label, dose-escalation phase I study of Illuminare-1, a novel fluorophore. Eligible patients were >18 years with a diagnosis of prostate adenocarcinoma scheduled to undergo minimally invasive radical prostatectomy. Exclusion criteria included prior pelvic surgery or radiation, known central/peripheral nervous system disease, significant renal dysfunction and clinically significant hepatic/liver dysfunction. The primary endpoints are to determine the safety of Illuminare-1 after IV administration and to determine the dose that achieves sustained, clinically useful fluorescence (scale of 1-5 with success being grade 4 fluorescence for 90 minutes) of the obturator nerve, the reference nerve for the study, to establish the dose for further studies. RESULTS: 18 patients have been evaluated in the dose escalation phase (0.25 mg/kg×3, 0.5 mg/kg×3, 1.0 mg/kg×10, and 1.5 mg/kg×2). Of 12 patients at 1.0-1.5 mg/kg dosing, 8 achieved grade 4 fluorescence lasting >90 minutes; 1 patient achieved fluorescence of 4 for 70 minutes. 3 patients achieved grade 4 fluorescence for 0, 66, and 87 minutes. One patient had a self-limited rash (Clavien 2), possibly attributable to the drug. CONCLUSIONS: The dose-escalation phase I study of Illuminare-1 has demonstrated promising results with minimal complications in the first 18 patients to receive the agent. We plan to identify a clinically useful and safe dose to inform further studies. Download PPT Source of Funding: Illuminare Biotechnologies © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e466 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Maria M. Pere More articles by this author Alex D. Doudt More articles by this author Trey D. Durdin More articles by this author Andrew W. Silagy More articles by this author Luke W. Dean More articles by this author Pedro Recabal More articles by this author Erica Levine More articles by this author Ouathek Ouerfelli More articles by this author Vanessa Thompson More articles by this author Alan Burke More articles by this author Melissa McCarter More articles by this author Christian Hernandez More articles by this author Andrew J. Vickers More articles by this author Peter T. Scardino More articles by this author Jonathan A. Coleman More articles by this author James A. Eastham More articles by this author Vincent P. Laudone More articles by this author Timothy F. Donahue More articles by this author Expand All Advertisement PDF downloadLoading ...