Skip to main content
OpenTrials
Completed

NCT Number: NCT02163083

Detection of Lymphnodes Using ICG During RARP

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology

Gronau, Moellenweg 22, 48599, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICG

Procedure

Improvement of detection of positive lymphnodes

Other names: indocyanine green powder, Pulsion Medical Systems, München, Germany

Primary outcomes

  1. The total number of detection rate of (positive) lymph nodes using ICG

    Time frame: during the surgery

Secondary outcomes

  1. Measurements of the time, that takes to remove the lymph nodes

    Time frame: During the surgery

Other outcomes

  1. Determine the anatomical location of the ICG-positive lymph node

    Time frame: During th surgery

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital Gronau

Other

Registry information

Official study title

Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jun 13, 2014
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.