Detection of Lymphnodes Using ICG During RARP

January 16, 2019 updated by: St. Antonius Hospital Gronau

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Moellenweg 22
      • Gronau, Moellenweg 22, Germany, 48599
        • St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Lymphadenectomy using standard Methods
Lymphadenectomy will be performed as a standard procedure
Experimental: Lymphadenectomy using ICG
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.
Procedure: ICG
Improvement of detection of positive lymphnodes
Other Names:
  • indocyanine green powder
  • Pulsion Medical Systems, München, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The total number of detection rate of (positive) lymph nodes using ICG
Time Frame: during the surgery
during the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurements of the time, that takes to remove the lymph nodes
Time Frame: During the surgery
During the surgery

Other Outcome Measures

Outcome Measure
Time Frame
Determine the anatomical location of the ICG-positive lymph node
Time Frame: During th surgery
During th surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital Gronau

Investigators

  • Principal Investigator: Jörn H. Witt, MD, St. Antonius Hospital Gronau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1157-6624
  • 2013-609-f-S (Other Identifier: ethical review committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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