NCT01110954终止2 期
Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Fluorescence intensity in breast cancer tissue
研究概览
简要总结
This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Caucasian female postmenopausal patients
- •Patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (T1 - T2)
排除标准
- •Suspicious lymphogenic metastases (cN1-3)
- •Acute or chronic hepatic diseases
- •Manifest renal diseases with renal dysfunction
- •Relevant cardiac disease
- •Preceding therapy of breast tumour under investigation
- •Patients with multiple attempts of hook-wire placement in preparation of surgery
- •Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
- •Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
研究组 & 干预措施
PD L 506 2nd dose
Active Comparator
Different dosage
干预措施: PD L 506 (Drug)
PD L 506
Experimental
干预措施: PD L 506 (Drug)
结局指标
主要结局
Fluorescence intensity in breast cancer tissue
时间窗: 3 h after intake of study medication
次要结局
- Laboratory data and adverse events(14 days)
研究者
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