NCT04606329
Completed
Phase 3
A Multicenter, Randomized, Open-label, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. Versus Charcotrace Inj. in Patients With Nonpalpable Breast Lesions
ConditionsBreast Diseases
Overview
- Phase
- Phase 3
- Intervention
- LuminoMark inj.(Conc. for fluorescence)
- Conditions
- Breast Diseases
- Sponsor
- Hanlim Pharm. Co., Ltd.
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Negative Resection margin rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •19 years ≤ age ≥ 80 years
- •Those who have lesion vial mammography and breast ultrasound
- •Those who be expected to do operation about non palpable breast lesion excision
- •Written consent voluntarily to participate in this clinical trial
Exclusion Criteria
- •Patients who be expected to do mastectomy
- •Patients with multiple tumor or diffuse microcalcification
- •Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection
- •Patients who were treated with moderate to severe radiotherapy
- •Patients who were treated with neoadjuvant Chemotherapy
- •Patients with active invading skin connective tissue disease
- •Patients with local progressing breast cancer or inflammatory local progressing breast cancer
- •Patients who have an allergy to investigational product or any of the component with the Investigational product
- •Patients who disagree about contraception for this clinical trial
- •A pregnant women or lactating women
Arms & Interventions
LuminoMark inj.
Injection LuminoMark inj. 0.2mL once in this study.
Intervention: LuminoMark inj.(Conc. for fluorescence)
Charcotrace Inj.
Charcotrace Inj. about 0.3\~1mL
Intervention: Charcotrace Inj.
Outcomes
Primary Outcomes
Negative Resection margin rate
Time Frame: Visit 5 (Day 14 ~Day 24)
The presence or absence of margin involvement in the resected breast lesions
Secondary Outcomes
- Pathologic perfection(Visit 5 (Day 14 ~Day 24))
- Technical success rate(Visit 3 (Day 0))
- Coloring confirmation rate of excision lesion(Visit 3 (Day 0))
- Pigmentation rate(Visit 5 (Day 14 ~Day 24))
- Re-operation rate(Visit 5 (Day 14 ~Day 24))
- Procedure complication rate(Visit 4, 5 (Day 1, Day 14 ~Day 24))
Study Sites (1)
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