NL-OMON49316已完成不适用
Image guided surgery for margin assessment of cutaneous squamous cell carcinoma during surgery: a phase I proof of concept study - Image guided skin cancer surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 cSCC and scheduled to undergo surgical
- •2) Age * 18 years;
- •3) Written informed consent;
- •4) Mentally competent person showing adequate potential for follow-up; For
- •female subjects who are of childbearing potential, are premenopausal with
- •intact reproductive organs or are less than 2 years post-menopausal:
- •5) A negative serum or urine pregnancy test prior to receiving the tracer.
- •6) Willing to ensure that she or her partner uses effective contraception
- •during the trial and for 6 months thereafter.
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-IRDye800CW;
- •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) Patients receiving Class IA (quinidine, procainamide) or Class III
- •(dofetilide, amiodarone, sotalol) antiarrhythmic agents;
- •10) Magnesium, potassium and calcium deviations that might lead to cardiac
- •rhythm (grade II or higher deviations by CTCAE).
- •11) Life expectancy < 26 weeks;
- •12) Karnofsky performance status < 70%.
研究者
相似试验
尚未招募
不适用
Image guided surgery for margin assessment of squamous cell carcinoma during Mohs micrographic surgery: a phase I proof of concept studyNL-OMON23751niversity Medical Center Groningen10
进行中（未招募）
1 期
visualisation with fluorescence (cetuximab-IRDye800CW) if tumor is left behind after surgical removal in the head & neck areaPatients with squamous cell carcinoma in the head & neck regionMedDRA version: 19.1Level: LLTClassification code 10043516Term: Throat cancer NOSSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10077425Term: Skin cancer excisionSystem Organ Class: 100000004865MedDRA version: 19.1Level: LLTClassification code 10023827Term: Laryngeal cancer NOSSystem Organ Class: 100000004864MedDRA version: 19.1Level: PTClassification code 10068979Term: Imaging procedureSystem Organ Class: 10022891 - InvestigationsMedDRA version: 19.1Level: LLTClassification code 10030961Term: Oral cancer stage unspecifiedSystem Organ Class: 100000004864EUCTR2016-002726-37-NLniversity Medical Center
已完成
2 期
IMAGE GUIDED SURGERY FOR MARGIN ASSESSMENT OF HEAD & NECK CANCER USING CETUXIMAB-IRDYE800CW CONJUGATE (ICON)squamous cell carcinomaNL-OMON47640niversitair Medisch Centrum Groningen88
Unknown
不适用
Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex TumorsBuccal Mucosa CancerGingival CancerNCT03137953HealthCare Global Enterprise Ltd.30
Unknown
不适用
Dermatoscopy Guided Resection for Skin CancerCutaneous Squamous Cell CarcinomaSurgical MarginBasal Cell CarcinomaNCT06342297Region Örebro County400