Real-time margin assessment in head and neck cancer - enhancing specificity by combining fresh frozen sectioning with targeted fluorescence imaging The LIGHTNING study
- Conditions
- Head and neck canceroral squamous cell carcinoma10072990
- Registration Number
- NL-OMON51847
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
- 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Macroscopic fluorescent signals on the excised tissue specimen and tracer<br /><br>distribution observed with fluorescence imaging;<br /><br>- Detection rates of tumor-positive margins and close margins using<br /><br>fluorescence imaging and FFS;<br /><br>- Number of additional resections based on the obtained fluorescent imaging and<br /><br>FFS data. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Patient characteristics (age, sex, BMI, history and morbidity, localization<br /><br>of primary tumor and lymph node metastasis, vital parameters and presence of<br /><br>symptoms before and after tracer administration);<br /><br>- Feasibility of on-site, intra-operative, tissue analysis by both surgeon and<br /><br>pathologist.<br /><br>- Feasibility of novel 3D imaging methods of the obtained additional biopsies<br /><br>(if clinical feasible) and correlation with standard histopathology </p><br>