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

NCT03743259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-06-06

No results posted yet for this study

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.

Conditions

  • Breast Diseases

Interventions

DRUG

LuminoMark inj. 0.1mL

Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.

DRUG

LuminoMark inj. 0.2mL

Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.

DRUG

Charcotrace Inj.

Injection Charcotrace Inj. about 0.3\~1mL once in this study.

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seok Won Kim, PI · Samsung Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03743259 on ClinicalTrials.gov