Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Enhanced intra-operative margin detection
研究概览
简要总结
To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG;
- •Age ≥ 18 years;
- •Written informed consent.
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-800CW;
- •History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT >3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment;
- •Inadequately controlled hypertension with or without current antihypertensive medications;
- •History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies;
- •Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. 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 1a (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- •Life expectancy < 12 weeks;
研究组 & 干预措施
75mg cetuximab + 15mg cetuximab-800CW
To investigate if study drugs can assist in tumor-positive margin detection
干预措施: Fluorescence guided detection of tumor positive margins (Procedure)
75mg cetuximab + 15mg cetuximab-800CW
To investigate if study drugs can assist in tumor-positive margin detection
干预措施: Cetuximab-IRDye800 (Drug)
结局指标
主要结局
Enhanced intra-operative margin detection
时间窗: Postoperatively, i.e. 7-10 working days
To determine the feasibility of fluorescence imaging combined with fresh frozen sectioning of a fluorescence guided biopsy of the excised tissue specimen in an on-site intra-operative setting. Outcome parameter: Detection rate of tumor-positive margins based on standard of care histopathological H/E assessment compared to fresh-frozen section analysis combined with fluorescence
次要结局
未报告次要终点
研究者
Max J.H. Witjes
Prof. dr.
University Medical Center Groningen