Einfluss des BMI bei der Darstellung des Wächterlymphknotens mittels Indocyaningrün bei Patienten mit einem Mammakarzinom

• Conditions: A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2012-005788-28-AT
• Lead Sponsor: andeskrankenhaus Fedkirch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-30
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

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

Inclusion Criteria

-biopsy proven invasive breast cancer in women of any age over 18 years of age
-tumours measuring < 5cm in maximum diameter radiologically (mammography, ultrasound or MRI)
-no evidence of pathological axillary lymph nodes clinically or on ultrasound scan.
-SLNB recommended as part of their surgical management for breast cancer

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

women unable to provide informed consent
- history of previous breast cancer
- prior axillary surgery or breast excision biopsy
- prior axillary surgery or a diagnostic excision biopsy of the breast
- pregnant or lactating women
- hypersensitivity to indocyanine green (ICG) or to sodium iodide
- hypersensitivity to iodine
- patients with hyperthyroidism or toxic thyroid adenomas

Study & Design

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