drugset / Trial / NCT02287675

Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

NCT02287675

Phase 4 Completed 40 enrolled Kettering Health Network
RandomizedParallel-groupQuadruple-blindDiagnostic

Summary

To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).

Timeline

Start
2015-01-19
Primary completion
2017-01-23
Completion
2017-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sulfur Colloid Diagnostic / imaging agent Intramuscular
Comparator Technetium Tc 99m Tilmanocept Diagnostic / imaging agent 50 ug Intramuscular

Indications