Breast Diseases Clinical Trial
Official title:
A Multicenter, Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. (Conc. for Fluorescence) Localization in Patients With Nonpalpable Breast Lesions
Verified date | January 2019 |
Source | Hanlim Pharm. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.
Status | Completed |
Enrollment | 44 |
Est. completion date | April 22, 2019 |
Est. primary completion date | January 11, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Female, 19 years = age = 80 years 2. Those who be expected to do operation about non palpable breast lesion excision 3. Those who have lesion vial mammography and breast ultrasound 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanlim Pharm. Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | Coloring confirmation rate of excision lesion. | The proportion of colored excision lesion | Visit 3(Day 0) | |
Secondary | Technical success rate | The proportion of colored lesion when make an incision | Visit 3(Day 0) | |
Secondary | 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) | |
Secondary | Pigmentation | Check whether skin is pigmented or not | Visit 5(Day 10~Day 24) |
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