NCT01395706

ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes

Determination of the Sensitifity of ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes in Breast Cancer - a Monocenter Prospective Open-label Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Pulsion Medical Systems SE · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Considering the high diagnostic accuracy and less vulnerable staging and therapy procedures, SLNB has rapidly become the state of the art diagnostic for axillary staging in early breast cancer. Prior surgery, the so called sentinel lymph nodes are detected, harvested and histopathologically examined. The histopathologic status of the sentinel node thereby accurately reflects the status of the remaining axillary nodes. The sentinel lymph node biopsy allows minimizing risks and burdens for patients who very likely have no metastasis in the axillary lymph nodes sparing the ALND and reducing the risk of surgery and postoperative lymph oedema for instance. Contrarily to former procedure where an axillary lymph node dissection (ALND) was done each time, an ALND now only follows if the detected sentinel lymph node is metastatic. Routinely sentinel lymph nodes are mapped using radiocolloid tracers such as technetium, sometimes combined with a blue dye. However the infrastructure for a radioactive tracing is complex and not available easily: special techniques and equipment for the manufacturing of the radiocolloid as well as training in the use with radioisotopes are needed. For example, the application of radioactive markers needs a ready access to a nuclear medicine department, a pre-operative visit and an effective coordination between the involved disciplinesis. As these radioisotopes are formed by specialised, rare industry facilities availability is heavenly dependend and lack of radioisotopes with shortages in diagnostic procedures has already been reported. Furthermore radiocolloid mapping is associated with radioactive exposure of the concerned patients and health workers and imposes problems with surgical waste disposal. Novel methods for detecting sentinel lymph nodes which waive the pre-operative injection of the radioactive marker are currently investigated. One of these new methods is the application of a fluorescence marker for SLN detection. In this clinical trial a novel method for detecting the sentinel lymph node using indocyanine green, a fluorescent molecule shall by investigated.

Conditions

• Malignant Neoplasm of Breast

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-07-15
• Last updated: 2011-07-18

Locations

1 site across 1 country: Germany