ICG fluorescence technique for the detection of Sentinel Lymph Nodes

• Conditions: Breast cancer with indicated sentinel lymph node biopsy.; MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2011-003194-28-DE
• Lead Sponsor: PULSION Medical Systems SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-08
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

General operability

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

if a performance of investigations with radioactive traced iodide is planed, this has to be performed at least 1 week before or 1 week after ICG application

No clinically significant findings in the routine blood examinations

Female subjects must be either at least two years postmenopausal or must have a negative pregnancy test prior to Tc application and must use a highly effective means of birth control (birth control that, alone or in combination, result in a low failure rate of less than 1% per year when used consistently and correctly):
hormonal method of contraceptive,
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 protocol

Signed written informed consent to participate in this clinical trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

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 required

Missing signed written informed consent to participate in the clinical trial

Participation in a drug trial during the whole clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified