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Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery
Led by Alume Biosciences, Inc. · Updated on 2024-10-28
64
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be a minimum of 18 years of age
- Planning to proceed with surgery
- Willing to provide informed consent
- Sexually active patients must be willing to use an acceptable form of contraceptive during the study and for 30 days after
- Females of childbearing potential must have a negative pregnancy test at screening and during the study
You will not qualify if you...
- Prior surgery at the intended surgical site
- Abnormal cardiac rhythm not controlled by medication
- Moderate to severe renal impairment
- History of fluorescein allergy
- History of drug-related anaphylactic reaction
- Concurrent disease or condition that may interfere with study participation
- Any condition placing patient at high risk of treatment compliance, as judged by investigator
- Use of investigational product or device within 30 days before screening
Research Team
B
Barbara Stephens
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