Trials / Completed
CompletedNCT03743259
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
A Multicenter, Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. (Conc. for Fluorescence) Localization in Patients With Nonpalpable Breast Lesions
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Hanlim Pharm. Co., Ltd. · Industry
- Sex
- Female
- Age
- 19 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc. for fluorescence) localization in patients with nonpalpable breast lesions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-05-29
- Primary completion
- 2019-01-11
- Completion
- 2019-04-22
- First posted
- 2018-11-16
- Last updated
- 2019-06-06
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03743259. Inclusion in this directory is not an endorsement.