drugset / Trial / NCT01642511

Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

NCT01642511

Phase 2 Completed 407 enrolled Shandong Cancer Hospital and Institute
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2\~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

Timeline

Start
2012-01
Primary completion
2014-11
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Background Methylthioninium Unknown 4 ml Subcutaneous

Indications