NL-OMON54715尚未招募2 期
Real time Molecular Fluorescence and Narrow Band Imaging for detection of the Primary Cancer Lesion in Patients with a Metastatis of Unknown Primary Tumor in the Head and Neck - REFLECT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
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 64（—）
入选标准
- •- Cytology confirmed diagnosis of squamous cell carcinoma and scheduled to
- •undergo panendoscopy as decided by the Multi-Disciplinary Head and Neck Tumor
- •Board of the UMCG;
- •- The primary tumor was not identified during standard diagnostic work-up in
- •the outpatient clinic including physical head and neck examination,
- •laryngoscopy, X-thorax and CT, PET or MRI;
- •- Age >= 18 years;
- •- Written informed consent;
- •- Mentally competent person that is able and willing to comply with study
- •procedures.
排除标准
- •- Medical or psychiatric conditions that compromise the patient*s ability to
- •give informed consent;
- •- Concurrent uncontrolled medical conditions;
- •- Received an investigational drug within 30 days prior to the dose of
- •cetuximab-IRDye800CW;
- •- History of myocardial infarction, cerebrovascular accident, uncontrolled
- •cardiac heart failure, significant liver disease or unstable angina within 6
- •months prior to enrollment;
- •- Inadequately controlled hypertension with or without current antihypertensive
- •medications;
- •- History of infusion reactions to cetuximab or other monoclonal antibody
- •- Pregnant or lactating women. Documentation of a negative pregnancy test must
- •be available for women of childbearing potential. Woman of childbearing
- •potential are premenopausal women with intact reproductive organs and women
- •less than two years after menopause;
- •- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males
- •or greater than 450 ms in females);
- •- Patients receiving Class IA (quinidine, procainamide) or Class III
- •(dofetilide, amiodarone, sotalol) antiarrhythmic agents;
- •- Clinically significant abnormalities in magnesium, potassium and calcium
- •- Life expectancy < 12 weeks;
- •- Karnofsky performance status < 70%.
研究者
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