The purpose of our study is to evaluate patient safety parameters, pharmacokinetics, and ureteral fluorescence/ease of visualization of the compound IS-001, an intravenously administered, renally cleared indigo-cyanine dye in patients undergoing robotic total laparoscopic hysterectomy using the da Vinci Xi Firefly® fluorescent imaging system. Our study design is a Phase I Open Label Case Series Trial. Our intervention is the IV administration of increasing doses (10 mg, 20mg and 40mg) of IS-001 (2mg/mL) in each eight patient cohort. Pharmacokinetic data was collected at predefined intraoperative set points and at 2, 4, and 6 hours post-op to determine maximum blood concentration, total drug exposure, and time course of excretion. Subjective surgeon assessment of ureteral fluorescence was compared to computer calculations of fluorescence intensity to evaluate ease and duration of ureteral visualization using Firefly®. IS-001 appears safe in human subjects. Pharmacokinetic data is consistent with preclinical findings in animal subjects. Subjective surgeon assessment of ureteral fluorescence indicates rapid onset of ureteral fluorescence that persists to a clinically useful degree for 30+ minutes.
Richard Farnam, "IS-001: investigating a novel compound for fluorescent ureteral identification during robotic hysterectomy
(Conference Presentation)," Proc. SPIE 10478, Molecular-Guided Surgery: Molecules, Devices, and Applications IV, 104780X (Presented at SPIE BiOS: January 28, 2018; Published: 14 March 2018); https://doi.org/10.1117/12.2291974.5751485401001.
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