CTIS2023-504615-33-00进行中（未招募）1 期
Focus Green: Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREE
eiden University Medical Center0 个研究点目标入组 10 人开始时间: 2023年5月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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 65+（—）
- 性别
- All
入选标准
- •Diagnosed with liver metastases of colorectal origin for which surgical resection is proposed and meet at least one of the following criteria: a.Scheduled for surgical resection of >3 CRLM or; b.completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or; c.Scheduled for surgery because of a locally recurrent liver metastasis., =18 years old., Willing and capable to give informed consent before study specific procedures
排除标准
- •Patients with contraindications for SGM-101 a.History of any anaphylactic shock; b.Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate); c.Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections; d.Previous administration of SGM-101, Patients with contraindications for Indocyanine green: a.Allergy for shells and/or clamps b.Hyperthyroidism c.Known allergy for ICG, Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives
研究者
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