To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions

Phase 2 Completed 44 enrolled Hanlim Pharm. Co., Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.

Timeline

Start: 2018-05-29
Primary completion: 2019-01-11
Completion: 2019-04-22

Publications

Kim I, Choi HJ, Ryu JM, Lee SK, Yu JH, Lee JE, Nam SJ, Shin HJ, Kim SW. The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial. BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Charcotrace	Unknown	0.3 ml	—
Comparator	Charcotrace	Unknown	1 ml	—
Subject	LuminoMark	Diagnostic / imaging agent	0.1 ml	—
Subject	LuminoMark	Diagnostic / imaging agent	0.2 ml	—

To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions

Summary

Timeline

Publications

Drugs

Indications