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

Hanlim Pharm

Status and phase: Completed; Phase 2

Conditions: Breast Diseases

Treatments: Drug: Charcotrace Inj.; Drug: LuminoMark inj. 0.1mL; Drug: LuminoMark inj. 0.2mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03743259

HL_LMN_201

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female, 19 years ≤ age ≥ 80 years
2. Those who be expected to do operation about non palpable breast lesion excision
3. Those who have lesion vial mammography and breast ultrasound
4. Written consent voluntarily to participate in this clinical trial

Exclusion criteria

1. Patients who be expected to do mastectomy
2. Patients with multiple tumor or diffuse microcalcification
3. Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection
4. Patients who were treated with moderate to severe radiotherapy
5. Patients who were treated with neoadjuvant Chemotherapy
6. Patients with active invading skin connective tissue disease
7. Patients with local progressing breast cancer or inflammatory local progressing breast cancer
8. Patients who have an allergy to investigational product or any of the component with the Investigational product
9. Patients who disagree about contraception for this clinical trial
10. A pregnant women or lactating women
11. Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent
12. Patients who investigators determines unsuitable for this clinical trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

LuminoMark inj. 0.1mL

Experimental group

Description:

Injection LuminoMark inj. 0.1mL once in this study.

Treatment:

Drug: LuminoMark inj. 0.1mL

LuminoMark inj. 0.2mL

Experimental group

Description:

Injection LuminoMark inj. 0.2mL once in this study.

Treatment:

Drug: LuminoMark inj. 0.2mL

Charcotrace Inj.

Active Comparator group

Description:

Charcotrace Inj. about 0.3\~1mL

Treatment:

Drug: Charcotrace Inj.