Evaluation of Two Techniques for the SLN Detection in BC Patients

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The revision of our data shows that since its introduction in our institution (Jules Bordet Institute) in 1998 (until 2010, the year of the last review of cases), 53 patients underwent neoadjuvant therapy before selective sentinel lymph node dissection followed by conventional axillary dissection.

The analysis of these cases shows that:

• The lack of demonstration of sentinel lymph nodes observed in 8 cases (6 cN0) is associated in 75% of them with a pN+ status

• If scintigraphic imaging is "positive" (demonstration of the sentinel lymph nodes: 35 cN0 and 10 cN+), our results appear favorable with a single false negative SLN result (False Negative Rate = 1/20 or 5%).

Therefore we propose additional technique for LN detection by indocyanine green, we hypothesize that the combination of two different injections improves the technique of sentinel lymph node biopsy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute

Criteria

Inclusion Criteria:

• Female patients submitted to mastectomy or tumorectomy with Complete Axillary Node Dissection (but to whose SLN procedure might be proposed in the future).

• General operability.

• Informed consent form signed

Exclusion Criteria:

• Age less than18 years old.

• Former operation in the axilla and/or breast.

• Any previous radiotherapy at the concerned breast and/or axilla and/or chest wall.

• 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 disseminated autonomies of the thyroid gland.

• Documented coronary disease.