ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes
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.
Malignant Neoplasm of Breast
Procedure: ICG Fluorescence technique
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
- Sensitivity using ICG [ Time Frame: 5 to 11 days ] [ Designated as safety issue: No ]Intraindividual: number of tumour-involved fluorescent positive sentinel lymph nodes / total number tumour-involved Technetium positive sentinel lymph nodes
- Specificity using ICG [ Time Frame: 5 to 11 days ] [ Designated as safety issue: Yes ]
Specificity using ICG:
number of patients with fluorescent positive sentinel lymph nodes that are not tumour - involved / number of patients with Tc positive SLN
False negative rate:
Number of patients where no sentinel lymph node is detected with Tc but with ICG / total number of patients with at least one Tc positive SLN
Detection rate for the SLN using the ICG fluorescence imaging method:
number of patients with at least one fluorescent sentinel lymph node per total number of patients treated with ICG Safety and tolerability of the IMP
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: ICG flourescence 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.
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
Other Name: Indocyanine Green (ICG)
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.
|Contact: Diethelm Wallwiener, Prof. Dr.||++49-7071-29-82-0 ext -246||Diethelm.Wallwiener@med.uni-tuebingen.de|
|University Department of Gynecology and Obstetrics|
|Tuebingen, Germany, 72076|
|Principal Investigator:||Diethelm Wallwiener, Prof. Dr.||University Hospital Tuebingen, University Department of Gynecology and Obstetrics|