NL-OMON50556已完成不适用
Fluorescence Molecular Endoscopy and Molecular Fluorescence-guided Surgery of locally advanced rectal cancer using cetuximab-IRDye800CW: a single-center feasibility safety study. - TRACT-II: Fluorescence Endoscopy and Surgery of Rectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
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
- •- Locally advanced rectal cancer, in multi-disciplinary colorectal oncology
- •meeting agreed on long course neoadjuvant chemoradiotherapy, followed by
- •surgical removal of the primary tumor;
- •- Age >= 18 years;
- •- Written informed consent.
排除标准
- •- Medical or psychiatric conditions that compromise the patient*s ability to
- •give informed consent;
- •- Concurrent uncontrolled medical conditions;
- •- Pregnancy or breast feeding. A negative pregnancy test must be available for
- •women of childbearing potential (i.e. premenopausal women with intact
- •reproductive organs and women less than two years after menopause);
- •- Received an investigational drug within 30 days prior to the dose of
- •cetuximab-IRDye800CW;
- •- History of infusion reactions to cetuximab or other monoclonal antibodies;
- •- Had within 6 months prior to enrollment: myocardial infarction,
- •cerebrovascular accident, uncontrolled cardiac heart failure, significant liver
- •disease, unstable angina pectoris;
- •- Patients receiving Class IA (quinidine, procainamide) or Class III
- •(dofetilide, amiodarone, sotalol) antiarrhythmic agents;
- •- Evidence of QT prolongation on an ECG made within three months prior to
- •inclusion (greater than 440 ms in males or greater than 450 ms in females);
- •- Magnesium, potassium and calcium lower than the lower limit of normal range,
- •determined within three months prior to inclusion.
研究者
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