Actively Recruiting
Feasibility Study of Bevonescein for Nerve and Ureter Visualization During Minimally Invasive Abdominopelvic Surgery
Led by Alume Biosciences, Inc. · Updated on 2024-10-28
64
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate Bevonescein, a sterile intravenous drug, in patients undergoing minimally invasive abdominopelvic surgery. The study focuses on assessing the safety, tolerability, and effectiveness of Bevonescein in highlighting nerves and ureters during surgery. It also investigates how the drug behaves in the body and the dose needed to produce clear fluorescent imaging for nerve and ureter visualization. Participants will receive Bevonescein during two study phases a dose defining phase and a dose expansion phase for each surgical setting. The drug is given as an intravenous infusion, and the study uses specialized imaging systems to record fluorescence signals in targeted tissues. These phases help determine the optimal dose and gather safety and imaging data. Throughout the study, participants will be monitored with fluorescence system surveys approximately 28 days after dosing, plus or minus 5 days. Researchers will collect data on the drugs imaging effects and safety. The total duration includes screening, dosing, and follow-up assessments to evaluate Bevonesceins performance during minimally invasive surgery.
CONDITIONS
Brief Title
A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery
Research Team
B
Barbara Stephens
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