2025-522027-95-00招募中3 期
Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer: Clinical Validation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort
研究概览
简要总结
This trial aims to improve and investigate intraoperative margin detection and pathologist-surgeon feedback using fluorescence-guided surgery in head-and-neck cancer patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 as determined by study team
- •Concurrent uncontrolled medical conditions as judged by the primary physician of the patient
- •Participated in a clinical trial in which an investigational drug was administrated within 30 days prior to the dose of cetuximab-800CW
- •History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure with significant risk of cetuximab not being tolerated, as determined by the treating physician
- •Inadequately controlled hypertension – as defined by the treating physician – with or without current antihypertensive medications
- •History of allergy or infusion reactions to 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
- •Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •Life expectancy < 12 weeks, as judged by the treating physician
结局指标
主要结局
Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort
Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort
次要结局
- Determining diagnostic parameters (including predictive values, sensitivity, specificity, type I & II errors) of fluorescence imaging for identifying inadequate tumor margins.
- Implementation of an intraoperative feedback workflow between the pathology department and surgery team on the margin assessment by FI.
- Retrospective comparison between standard fluorescence imaging devices and a novel technique using dual aperture fluorescence imaging as an exploratory objective.
研究者
Prof. Dr. M.J.H. Witjes
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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