Real-time margin assessment in head and neck cancer - enhancing specificity by combining fresh frozen sectioning with targeted fluorescence imaging The LIGHTNING study - Lightning study

niversitair Medisch Centrum Groningen0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- 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.

•- Medical or psychiatric conditions that compromise the patient*s ability to
•give informed consent;
•- Concurrent uncontrolled medical conditions;
•- 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, 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 IA (quinidine, procainamide) or Class III
•(dofetilide, amiodarone, sotalol) antiarrhythmic agents.
•- Life expectancy < 12 weeks;

发起方