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ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes

NCT01395706 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2011-07-18

No results posted yet for this study

Summary

Objectives of Clinical Trial

The main objective of this clinical trial is to show the efficacy of fluorescence lymphangiography with indocyanine green (ICG) for the detection of sentinel lymph nodes.

Conditions

  • Malignant Neoplasm of Breast

Interventions

PROCEDURE

ICG Fluorescence technique

This is an uncontrolled, non-randomised, open-label, monocenter clinical trial. A total of n=125 subjects will participate in this clinical trial. No clinical trial participant will be allowed to be included in this trial more than once. 10 mg (5mg/ml)per injection are applicated

Sponsors & Collaborators

  • Pulsion Medical Systems SE

    lead INDUSTRY

Principal Investigators

  • Diethelm Wallwiener, Prof. Dr. · University Hospital Tuebingen, University Department of Gynecology and Obstetrics

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01395706 on ClinicalTrials.gov