NL-OMON48019已完成不适用
Multispectral optoacoustic imaging using cetuximab-800CW for detection of cervical lymph node metastases: a single center proof of concept study - OPUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- Observational non invasive
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, the subject must meet the inclusion criteria of the ICON study (NCT03134846), which are as follows:
- •1. Biopsy confirmed diagnosis of primary or recurrent HSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head & Neck Tumor Board of the UMCG.
- •2. Age * 18 years
- •3. Written informed consent
- •4. Adequate potential for follow up
- •5. Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires.
排除标准
- •Patients will be excluded when they meet one of the exclusion criteria of the ICON study (NCT03134846), which are as follows:
- •1. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent;
- •2. Concurrent uncontrolled medical conditions;
- •3. Received an investigational drug within 30 days prior to the dose of cetuximab-IRDye800CW;
- •4. Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible;
- •5. Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
- •6. Inadequately controlled hypertension with or without current antihypertensive medications;
- •7. History of infusion reactions to cetuximab or other monoclonal antibody therapies
- •8. 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;
- •9. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females);
- •10. Lab values that in the opinion of the primary surgeon would prevent surgical resection;
- •11. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents;
- •12. Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE);
- •13. Life expectancy < 12 weeks;
- •14. Karnofsky performance status < 70%.
研究者
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