NL-OMON49733招募中2 期
Guided by light: Optimizing surgical excision of oral cancer using real-time fluorescence imaging - Guided by Light
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
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. Patients with biopsy-proven squamous cell carcinoma of the oral
- •cavity, eligible for surgical resection of the primary tumor;
- •2. Patients >= 18 years of age;
- •3. Before patient registration, written informed consent must be given
- •according to ICH/GCP, and national/local regulations.
排除标准
- •1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- •2. History of a clinically significant allergy or anaphylactic reactions to
- •any of the components of the agent.
- •3. Patients pregnant or breastfeeding, lack of effective contraception in
- •male or female patients with reproductive potential;
- •4. Patients with renal insufficiency (eGFR<60);
- •5. Patients with a previous kidney transplantation in the medical history;
- •6. Patients using medications that may significantly impair renal function
- •(i.e. NSAIDs, particularly COX-2 inhibitors);
- •7. Immuno-compromised patients who do not have the ability to respond
- •normally to an infection due to an impaired on weakened immune
- •system, caused by either a pre-existing disease or concomitant
- •medications;
- •8. Any condition that the investigator, anesthesiologist or head- and
- •neck surgeon considers to be potentially jeopardizing to the patient's wellbeing
- •or the study objectives.
研究者
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