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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 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])
研究概览
简要总结
This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 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
- Non 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 19 years ≤ age ≥ 80 years
- •Those who be expected to do operation about non palpable breast lesion excision
- •Those who have lesion vial mammography and breast ultrasound
- •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. 0.1mL
Injection LuminoMark inj. 0.1mL once in this study.
干预措施: LuminoMark inj. 0.1mL (Drug)
LuminoMark inj. 0.2mL
Injection LuminoMark inj. 0.2mL once in this study.
干预措施: LuminoMark inj. 0.2mL (Drug)
Charcotrace Inj.
Charcotrace Inj. about 0.3~1mL
干预措施: Charcotrace Inj. (Drug)
结局指标
主要结局
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])
时间窗: Visit 3(Day 0)
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.
次要结局
- Coloring confirmation rate of excision lesion.(Visit 3(Day 0))
- Technical success rate(Visit 3(Day 0))
- 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])(Visit 3(Day 0))
- Pigmentation(Visit 5(Day 10~Day 24))