NL-OMON53334招募中2 期
SGM-101 tumor-targeted fluorescence endoscopy to enable discrimination of malignant from benign tissue in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia: a feasibility study - SGM-T1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Patient must have suspected HGD/T1RC and scheduled for a local endoscopic
- •en-bloc resection. The rectum is defined as the area between the linea dentata
- •and 10cm ab ano.
- •2. Age > 18 years old
- •3. Patients should be capable and willing to give signed informed consent
- •before study specific procedures.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study
- •1. Prior participation in this study
- •2. Previous administration of SGM-101
- •3. Patients with a history of anaphylactic shock
- •4. Patients pregnant or breastfeeding, lack of effective contraception in male
- •or female patients with reproductive potential
- •5. Any condition that the investigator considers to be potentially jeopardizing
- •the patients* well-being or the study objectives.
研究者
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