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Impact of Intraoperative ICG on Functional Outc in RARP

NCT06446648 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Prostate Adenocarcinoma

Interventions

DRUG

ICG

Administer an IV ICG injection intraoperatively, using the optimal dosage and timing defined in the second phase of the study. Utilize the newly developed 3D vascular map for visualization of the arteries before and after prostate resection.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • David Lee, MD · Chao Family Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2028-07-31
Completion
2030-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446648 on ClinicalTrials.gov