drugset / Trial / NCT02294565

VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer

NCT02294565

NaSingle-groupOpen-label

Summary

The purpose of this Phase 1 portion of this clinical research study is to find out what dose of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node Biopsy procedure) in patients diagnosed with breast cancer. The purpose of the Phase 2 portion of this clinical research study is to find out if giving dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can help surgeons localize the lymph nodes that need to be removed in patients diagnosed by breast cancer.

Timeline

Start
2014-06
Primary completion
2016-01
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Technetium Tc-99m Sulfur Colloid Diagnostic / imaging agent Other
Subject VST-1001 Diagnostic / imaging agent Other