SLN detection in breast cancer patients by fluorescencet imaging

• Conditions: Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG for breast cancer patients.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2013-001555-12-BE
• Lead Sponsor: Jules Bordet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Female patients with cT2N0M0 unifocal breast cancer where SLN may be proposed.
- General operability.

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 214
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age less than18 years old.
- Multifocal cancer
- Former operation in the axilla and/or breast.
- Any previous radiotherapy at the concerned breast and/or axilla and/or chest wall.
- Definite lymph node metastases.
- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or dissemi-nated autonomies of the thyroid gland.
- Documented coronary disease.
- Advanced renal impairment (creatinine > 1,5mg/dl).
- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
- Pregnancy, breastfeeding

Study & Design

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