Breast Diseases
Conditions
Keywords
Nonpalpable Breast Lesions
Brief summary
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
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.
Interventions
DRUGLuminoMark inj.(Conc. for fluorescence)
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
DRUGCharcotrace Inj.
Injection Charcotrace Inj. about 0.3\ 1mL once in this study.
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 19 years ≤ age ≥ 80 years 2. Those who have lesion vial mammography and breast ultrasound 3. Those who be expected to do operation about non palpable breast lesion excision 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Resection margin rate | Visit 5 (Day 14 ~Day 24) | The presence or absence of margin involvement in the resected breast lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coloring confirmation rate of excision lesion | Visit 3 (Day 0) | The proportion of colored excision lesion |
| Pathologic perfection | Visit 5 (Day 14 ~Day 24) | 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. \[Pathologic perfection = the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery\] |
| Technical success rate | Visit 3 (Day 0) | The proportion of colored lesion when make an incision |
| Re-operation rate | Visit 5 (Day 14 ~Day 24) | The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results. |
| Procedure complication rate | Visit 4, 5 (Day 1, Day 14 ~Day 24) | Evaluate the numbers of subjects with procedure complication after lesion removal |
| Pigmentation rate | Visit 5 (Day 14 ~Day 24) | Check whether skin is pigmented or not |
Countries
South Korea
Outcome results
None listed