2024-512824-13-01招募中2 期
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Rate of adequate (i.e. >5mm clear) tumor resection margins.
研究概览
简要总结
To improve adequate resection of oral cancer using fluorescent imaging technology:
- To determine the recommended dose for the highest tumor-tobackground ratio (TBR) of at least >1.5 using cRGD-ZW800-1 in oral cancer;
- To increase the rate of adequate (i.e. >5mm clear) tumor resection margins
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- •Patients ≥ 18 years of age;
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- •History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- •Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- •Patients with renal insufficiency (eGFR<60);
- •Patients with a previous kidney transplantation in the medical history;
- •Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);
- •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;
- •Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient's wellbeing or the study objectives.
结局指标
主要结局
Rate of adequate (i.e. >5mm clear) tumor resection margins.
Rate of adequate (i.e. >5mm clear) tumor resection margins.
次要结局
- Sensitivity, specificity, positive and negative predictive values
- Co-localization of FLI with immunohistochemistry on pathology slides
- Percentage of extra tissue resection based on FLI-driven frozen sections
- Operation time
- FLI of lymph node metastases after neck dissection
研究者
Stijn Keereweer
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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