Detection of Lymphnodes Using ICG During RARP | NCT02163083

Studies
Detection of Lymphnodes Using ICG During RARP

NCT02163083

Sponsor

St. Antonius Hospital Gronau

Status

Completed

Last Update Posted

Jan 18, 2019Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-609-f-S	Other Identifier	ethical review committee

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014Actual

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2017Actual

First Submitted Date

Jun 10, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2019

Last Update Posted Date

Jan 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lymphadenectomy using standard Methods	No Intervention	Lymphadenectomy will be performed as a standard procedure
Lymphadenectomy using ICG	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.	Procedure: ICG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICG	Procedure	Improvement of detection of positive lymphnodes	Lymphadenectomy using ICG

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jörn H. Witt, MD	St. Antonius Hospital Gronau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology		Gronau	Moellenweg 22	48599	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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