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Relationship bw Image-deriv Features of Intraoperative ICG Visualiz of NVBs During RARP & Functional Outcome

Prostate Adenocarcinoma Clinical Trial

Official title:
Relationship Between Image-derived Features of Intraoperative ICG Visualization of Periprostatic Vasculature and NVBs During RARP and Functional Outcomes

Clinical Trial Summary

This is a pilot, 3 phases open-label feasibility study with the 3rd phase consisting of randomized 2-arm intervention trial, to assess the systematic use of indocyanine green (ICG) in subjects with prostate adenocarcinoma during robot-assisted radical prostatectomy and its impact on sexual function outcomes at 12 months postoperatively.

Clinical Trial Description

The first phase of this study will involve performing 50 cases of nerve-sparing RARP on patients who are good candidates for nerve sparing. During these procedures, we will record the location and size of arteries encountered to create a detailed 3D map of the surgical arterial vasculature. In the second phase, we will recruit another 50 patients. These patients will receive an IV injection of ICG before encountering the arteries to visualize them prior to resection. This phase will determine the optimal dosage and timing for the IV ICG injection. The third phase will utilize the dosage and timing defined in the second phase. This phase will be a randomized trial involving 300 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06446648
Study type Interventional
Source University of California, Irvine
Contact Chao Family Comprehensive Cancer Center University of California
Phone 1-877-827-8839
Email ucstudy@uci.edu
Status Not yet recruiting
Phase Early Phase 1
Start date June 15, 2024
Completion date June 2028
View Details
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