NL-OMON49605尚未招募不适用
Fluorescent Guided Surgery in Penile Carcinoma using Cetuximab-800CW - GLANS
niversitair Medisch Centrum0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
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
- •1. Biopsy confirmed diagnosis of primary or recurrent PSCC and scheduled to
- •undergo surgical resection of primary or recurrent tumor with or without
- •(sentinel) lymph node procedure as decided by the Urology Department of the
- •2. Age >= 18 years
- •3. Written informed consent
- •4. Adequate potential for follow-up
排除标准
- •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-800CW
- •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
- •8. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in
- •males or greater than 450 ms in females)
- •9. Lab values that in the opinion of the primary surgeon would prevent surgical
- •10. Patients receiving Class Ia (quinidine, procainamide) or Class III
- •(dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •11. Magnesium, potassium and calcium deviations that might lead to cardiac
- •rhythm (grade II or higher deviations by CTCAE)
- •12. Life expectancy < 12 weeks
- •13. Karnofsky performance status < 70%
研究者
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