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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Injection Charcotrace Inj. about 0.3\~1mL once in this study.
Samsung Medical Center
Seoul, South Korea
Negative Resection margin rate
The presence or absence of margin involvement in the resected breast lesions
Time frame: Visit 5 (Day 14 ~Day 24)
Technical success rate
The proportion of colored lesion when make an incision
Time frame: Visit 3 (Day 0)
Coloring confirmation rate of excision lesion
The proportion of colored excision lesion
Time frame: 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. \[Pathologic perfection = the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery\]
Time frame: Visit 5 (Day 14 ~Day 24)
Pigmentation rate
Check whether skin is pigmented or not
Time frame: 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.
Time frame: Visit 5 (Day 14 ~Day 24)
Procedure complication rate
Evaluate the numbers of subjects with procedure complication after lesion removal
Time frame: Visit 4, 5 (Day 1, Day 14 ~Day 24)
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