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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

Phase 2
18 Years
80 Years
Not Enrolling
Malignant Neoplasm of Breast

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Trial Information

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.

Inclusion Criteria:

- Early breast cancer: histopathologically confirmed diagnosis, maximum tumour stage T1
and T2, therefore diameter < 5 cm, unifocal tumour or multifocal tumour Grading
G1-G3, invasive ductal and / or invasive lobar carcinoma ≤ 5 cm diameter

- Indicated sentinel lymph node biopsy as part of the patient's routine management for
breast cancer

- Age: 18 - 80 years, inclusive

- Gender: male and female

- BMI: ≤ 30

- Non-smoker (for at least the previous 3 months)

- General operability

- Intact site-specific anatomy at the concerned breast and /or axilla for ensuring an
adequate lymphangiography

- Performance of investigations with radioactive traced iodide at least 1 week before
and 1 week after ICG application

- No clinically significant findings in the routine blood examinations

- Female subjects with childbearing potential must have a negative pregnancy test prior
Tc application and must be either at least two years postmenopausal or using a highly
effective mean of birth control (birth control that, alone or in combination, result
in a low failure rate of less than 1 percent per year when used consistently and

- hormonal method of contraception,

- surgical sterility,

- double barrier methods,

- intrauterine contraceptive device,

- lifestyle with a personal choice of abstinence,

- bilateral vasectomy of sexual partner at least 3 months prior to enrolment in
combination with barrier methods

- Willing and able to complete screening and study procedures, as described in the

- Signed written informed consent to participate in this clinical trial

Exclusion Criteria:

- Breast cancer: stage T3 or T4 carcinoma, inflammatory or exulcerated mamma carcinoma

- Former operation in axilla

- Any previous radiotherapy at the concerned breast and / or axilla and / or chestwall

- Definite lymph node metastases (ultrasound and / or fine-needle aspiration) (definite
nodal positive patients in fine-needle aspiration)

- Contraindication for technetium imaging

- History of allergy or hypersensitivity against the investigational medicinal products
(its active substance or ingredients)

- History of intolerability to ICG-Pulsion during a previous injection, as this may
lead to serious anaphylactic reactions

- History of allergic diseases / hypersensitivities, unless the investigator considers
the allergic disease as clinically irrelevant for the purpose of this clinical trial

- Allergy to iodine or to shellfish

- Any other contraindication to one of the investigational medicinal products as
described in their Summary of Product Characteristics

- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or
disseminated autonomies of the thyroid gland

- Advanced renal impairment (creatinine > 1,5mg/dl)

- Complete lymphatic obstruction

- All clinically relevant internal medicinal diseases, cardiac or renal that could
impair the outcome of the clinical trial or that in the investigator's mind are not
compatible with participation for medical reasons

- Acute inflammatory or febrile illness

- Evidence of local inflammation at the site of surgery

- Concurrent medication or any medication during the 2 weeks preceeding the enrolment
which reduce or increase the extinction of ICG (i.e. anticonvulsants, haloperidol)

- Current or recent history of illicit drug or alcohol abuse, or dependence as defined
as the continued use of alcohol or drugs despite the development of social, legal, or
health problems

- Psychiatric or cognitive impairment that, in the opinion of the investigator, would
interfere with the subject's ability to comply with the study requirements (e.g.
Alzheimer's disease)

- Pregnancy, breastfeeding

- Inability to understand the nature and the extent of the trial and the procedures

- Missing signed written informed consent to participate in the clinical trial

- Participation in a drug trial during the whole clinical trial

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity using ICG

Outcome Description:

Intraindividual: number of tumour-involved fluorescent positive sentinel lymph nodes / total number tumour-involved Technetium positive sentinel lymph nodes

Outcome Time Frame:

5 to 11 days

Safety Issue:


Principal Investigator

Diethelm Wallwiener, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Tuebingen, University Department of Gynecology and Obstetrics


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

September 2011

Completion Date:

March 2012

Related Keywords:

  • Malignant Neoplasm of Breast
  • Malignant Neoplasm of Breast
  • Sentinel lymph node detection
  • ICG fluorescence technique
  • Population of male and female patients with mamma carcinoma
  • Breast Neoplasms
  • Neoplasms