The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adverse Events
Timeframe: 30 days
Pharmacodynamics
Timeframe: during surgery
Pharmacodynamics
Timeframe: During surgery
Cmax
Timeframe: 24 hours
AUCinf
Timeframe: 24 hours
AUClast
Timeframe: 24 hours
Tmax
Timeframe: 24 hours
t1/2
Timeframe: 24 hours