NCT04606329已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Negative Resection margin rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent
- •Patients who investigators determines unsuitable for this clinical trial
研究组 & 干预措施
LuminoMark inj.
Experimental
Injection LuminoMark inj. 0.2mL once in this study.
干预措施: LuminoMark inj.(Conc. for fluorescence) (Drug)
Charcotrace Inj.
Active Comparator
Charcotrace Inj. about 0.3~1mL
干预措施: Charcotrace Inj. (Drug)
结局指标
主要结局
Negative Resection margin rate
时间窗: Visit 5 (Day 14 ~Day 24)
The presence or absence of margin involvement in the resected breast lesions
次要结局
- 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))
研究者
研究点 (1)
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