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This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 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. 0.1mL | Experimental | Injection LuminoMark inj. 0.1mL once in this study. |
|
| LuminoMark inj. 0.2mL | 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. 0.1mL | Drug | Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excision perfection(It is a formula. This formula's calculation method is as follows. [Excision perfection = the longest diameter of removed lesion after surgery / the longest diameter of identified lesion via breast ultrasonography results]) | Excision perfection is how well the surgeon removed the lesion compared to an identified by breast ultrasonography. Visit 3, Investigators calculate 'Excision perfection' using by the formula. | Visit 3(Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Coloring confirmation rate of excision lesion. | The proportion of colored excision lesion | Visit 3(Day 0) |
| Technical success rate | The proportion of colored lesion when make an incision |
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Inclusion Criteria:
Exclusion Criteria:
Only female
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| Name | Affiliation | Role |
|---|---|---|
| Seok Won Kim, PI | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33726718 | Derived | Kim I, Choi HJ, Ryu JM, Lee SK, Yu JH, Lee JE, Nam SJ, Shin HJ, Kim SW. The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial. BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y. |
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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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| LuminoMark inj. 0.2mL | Drug | Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study. |
|
|
| Charcotrace Inj. | Drug | Injection Charcotrace Inj. about 0.3~1mL once in this study. |
|
|
| Visit 3(Day 0) |
| Pathologic perfection(It is a 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]) | Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 3, Investigators calculate 'Pathologic perfection' using by the formula. | Visit 3(Day 0) |
| Pigmentation | Check whether skin is pigmented or not | Visit 5(Day 10~Day 24) |
| D060328 |
| Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |