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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity using ICG
Intraindividual: number of tumour-involved fluorescent positive sentinel lymph nodes / total number tumour-involved Technetium positive sentinel lymph nodes
5 to 11 days
Diethelm Wallwiener, Prof. Dr.
University Hospital Tuebingen, University Department of Gynecology and Obstetrics
Germany: Federal Institute for Drugs and Medical Devices