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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LuminoMark inj. | Experimental | Injection LuminoMark inj. 0.2mL once in this study. |
|
| Charcotrace Inj. | Active Comparator | Charcotrace Inj. about 0.3~1mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LuminoMark inj.(Conc. for fluorescence) | Drug | Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005453 | Fluorescence |
| ID | Term |
|---|---|
| D049449 | Luminescence |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
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| Charcotrace Inj. | Drug | Injection Charcotrace Inj. about 0.3~1mL once in this study. |
|
| 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) |
| D060328 |
| Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |