drugset / Trial / NCT02032498

Evaluation of Two Techniques for the SLN Detection in BC Patients

NCT02032498

Phase 2 Unknown 214 enrolled Jules Bordet Institute
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2013-07
Primary completion
2014-10
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent Other

Indications