Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment icg
Sponsor St. Antonius Hospital Gronau
Start date July 2014
End date June 2016
Trial size 120 participants
Trial identifier NCT02163083, 2013-609-f-S, U1111-1157-6624

Summary

The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Lymphadenectomy will be performed as a standard procedure
(Experimental)
A fluorescent dye (indocyanine green) will be ultrasound-controlled preoperatively injected in the prostate. During robot-assisted radical intervention by DaVinci ® robot the lymphadenectomy is performed using the fluorescence lymphography.
icg indocyanine green powder
Improvement of detection of positive lymphnodes

Primary Outcomes

Measure
The total number of detection rate of (positive) lymph nodes using ICG
time frame: during the surgery

Secondary Outcomes

Measure
Measurements of the time, that takes to remove the lymph nodes
time frame: During the surgery

Eligibility Criteria

Male participants from 18 years up to 75 years old.

Inclusion Criteria: - Histologically confirmed locally limited prostate cancer; - Intermediate or high risk tumor - Recommended and planned prostatectomy; - Completed and signed written consent; - Voluntarily agreement to participate in this study - Age of the study participants ≥ 18 years. Exclusion Criteria: - Allergic reaction to active ingredient (indocyanine green); - Iodine allergy; - Hyperthyroidism; - High-grade renal impairment; - High-grade hepatic insufficiency; - Unwillingness to the storage and disclosure of pseudonymous disease and personal data - psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Additional Information

Official title Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
Principal investigator Jörn H. Witt, MD
Description ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. Antonius Hospital Gronau.