NCT04755920招募中2 期
A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
研究概览
简要总结
This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure;
- •Patients aged over 18 years old;
- •All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
- •Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
- •Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.
排除标准
- •History of any anaphylactic reaction;
- •Previous use of SGM-101;
- •Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
- •Laboratory abnormalities defined as:
- •Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
- •Total bilirubin above 2 times the ULN or;
- •Serum creatinine above 1.5 times the ULN or;
- •Platelet count below 100 x 109/L or;
- •Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
- •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;
- •Patients pregnant or breastfeeding;
- •Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
研究组 & 干预措施
Patients with colorectal brain metastases
Experimental
10 mg SGM-101, administration 3 to 5 days prior to surgery.
干预措施: SGM-101 (Drug)
结局指标
主要结局
To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
时间窗: Intraoperative
* Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; * Concordance between the fluorescent signal and the resection margin with the use of neuronavigation
次要结局
未报告次要终点
研究者
Alexander Vahrmeijer
Oncologic Surgeon - Hepatobiliary and Colorectal
Leiden University Medical Center
研究点 (2)
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