To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)

Study Overview
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Brief Summary
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This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Open-label, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. Versus Charcotrace Inj. in Patients With Nonpalpable Breast Lesions

Conditions
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Breast Diseases

Intervention / Treatment
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* Drug: LuminoMark inj.(Conc. for fluorescence)
* Drug: Charcotrace Inj.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years ≤ age ≥ 80 years Those who have lesion vial mammography and breast ultrasound Those who be expected to do operation about non palpable breast lesion excision Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients who be expected to do mastectomy Patients with multiple tumor or diffuse microcalcification Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection Patients who were treated with moderate to severe radiotherapy Patients who were treated with neoadjuvant Chemotherapy Patients with active invading skin connective tissue disease Patients with local progressing breast cancer or inflammatory local progressing breast cancer Patients who have an allergy to investigational product or any of the component with the Investigational product Patients who disagree about contraception for this clinical trial A pregnant women or lactating women Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent Patients who investigators determines unsuitable for this clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LuminoMark inj.<br>Injection LuminoMark inj. 0.2mL once in this study. | Drug: LuminoMark inj.(Conc. for fluorescence)<br>* Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.<br>|
| Active Comparator: Charcotrace Inj.<br>Charcotrace Inj. about 0.3 1mL | Drug: Charcotrace Inj.<br>* Injection Charcotrace Inj. about 0.3 1mL once in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Resection margin rate | The presence or absence of margin involvement in the resected breast lesions | Visit 5 (Day 14  Day 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | The proportion of colored lesion when make an incision | Visit 3 (Day 0) | 
| Coloring confirmation rate of excision lesion | The proportion of colored excision lesion | Visit 3 (Day 0) | 
| Pathologic perfection | Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 5, Investigators calculate 'Pathologic perfection' using by the formula. This formula's calculation method is as follows. [Pathologic perfection = the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery] | Visit 5 (Day 14  Day 24) | 
| Pigmentation rate | Check whether skin is pigmented or not | Visit 5 (Day 14  Day 24) | 
| Re-operation rate | The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results. | Visit 5 (Day 14  Day 24) | 
| Procedure complication rate | Evaluate the numbers of subjects with procedure complication after lesion removal | Visit 4, 5 (Day 1, Day 14  Day 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonpalpable Breast Lesions