Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
64
Bevonescein is a sterile solution that is intravenously administered
University of California San Diego
San Diego, California, United States
RECRUITINGFluorescence System Survey
To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.
Time frame: 28 (+5 days)
To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings
The optimal dose for each of the identified surgical settings will be assessed by using three doses.
Time frame: 28 (+5 days)
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