Back to resultsDetection of Lymphnodes Using ICG During RARP
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ICG
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Lymphadenectomy using standard Methods
Lymphadenectomy using ICG
Arm Description
Lymphadenectomy will be performed as a standard procedure
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.
Outcomes
Primary Outcome Measures
The total number of detection rate of (positive) lymph nodes using ICG
Secondary Outcome Measures
Measurements of the time, that takes to remove the lymph nodes
Full Information
NCT ID
NCT02163083
First Posted
June 10, 2014
Last Updated
January 16, 2019
Sponsor
St. Antonius Hospital Gronau
1. Study Identification
Unique Protocol Identification Number
NCT02163083
Brief Title
Detection of Lymphnodes Using ICG During RARP
Official Title
Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Antonius Hospital Gronau
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lymphadenectomy using standard Methods
Arm Type
No Intervention
Arm Description
Lymphadenectomy will be performed as a standard procedure
Arm Title
Lymphadenectomy using ICG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ICG
Other Intervention Name(s)
indocyanine green powder, Pulsion Medical Systems, München, Germany
Intervention Description
Improvement of detection of positive lymphnodes
Primary Outcome Measure Information:
Title
The total number of detection rate of (positive) lymph nodes using ICG
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
Measurements of the time, that takes to remove the lymph nodes
Time Frame
During the surgery
Other Pre-specified Outcome Measures:
Title
Determine the anatomical location of the ICG-positive lymph node
Time Frame
During th surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörn H. Witt, MD
Organizational Affiliation
St. Antonius Hospital Gronau
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology
City
Gronau
State/Province
Moellenweg 22
ZIP/Postal Code
48599
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Detection of Lymphnodes Using ICG During RARP
We'll reach out to this number within 24 hrs