Detection of Lymphnodes Using ICG During RARP

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163083
• Other study ID #: U1111-1157-6624
• Secondary ID: 2013-609-f-S
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: April 2017

Study information

• Verified date: January 2019
• Source: St. Antonius Hospital Gronau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• ICG
Improvement of detection of positive lymphnodes

Locations

Country	Name	City	State
Germany	St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology	Gronau	Moellenweg 22

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital Gronau

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine the anatomical location of the ICG-positive lymph node		During th surgery
Primary	The total number of detection rate of (positive) lymph nodes using ICG		during the surgery
Secondary	Measurements of the time, that takes to remove the lymph nodes		During the surgery