Fluorescence Molecular Endoscopy and Molecular Fluorescence-guided Surgery of locally advanced rectal cancer using cetuximab-IRDye800CW: a single-center feasibility safety study.
- Conditions
- 10017991Rectal cancer10017990
- Registration Number
- NL-OMON50556
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
- Locally advanced rectal cancer, in multi-disciplinary colorectal oncology
meeting agreed on long course neoadjuvant chemoradiotherapy, followed by
surgical removal of the primary tumor;
- Age >= 18 years;
- Written informed consent.
- Medical or psychiatric conditions that compromise the patient*s ability to
give informed consent;
- Concurrent uncontrolled medical conditions;
- Pregnancy or breast feeding. A negative pregnancy test must be available for
women of childbearing potential (i.e. premenopausal women with intact
reproductive organs and women less than two years after menopause);
- Received an investigational drug within 30 days prior to the dose of
cetuximab-IRDye800CW;
- History of infusion reactions to cetuximab or other monoclonal antibodies;
- Had within 6 months prior to enrollment: myocardial infarction,
cerebrovascular accident, uncontrolled cardiac heart failure, significant liver
disease, unstable angina pectoris;
- Patients receiving Class IA (quinidine, procainamide) or Class III
(dofetilide, amiodarone, sotalol) antiarrhythmic agents;
- Evidence of QT prolongation on an ECG made within three months prior to
inclusion (greater than 440 ms in males or greater than 450 ms in females);
- Magnesium, potassium and calcium lower than the lower limit of normal range,
determined within three months prior to inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>General main study parameter:<br /><br>- Evaluating vital parameters, ECG, adverse events (AE), serious adverse events<br /><br>(SAE) and suspected unexpected serious adverse reactions (SUSAR) for safety<br /><br>assessment;<br /><br>Main study parameter for endoscopy part:<br /><br>- Macroscopic fluorescent signal levels (tumor-to-background ratio) observed by<br /><br>NIR fluorescence imaging correlated to histology between tumor and normal<br /><br>rectal tissue.<br /><br>Main study parameter for surgical part:<br /><br>- Macroscopic fluorescent signal levels (tumor-to-background ratio) observed by<br /><br>NIR fluorescence imaging correlated to histology for resection margins.</p><br>
- Secondary Outcome Measures
Name Time Method <p>General secondary study parameters:<br /><br>- Quantification of fluorescence through analyses of spectroscopy measurements;<br /><br>- Fluorescence distribution on a microscopic level for assessment of tracer<br /><br>localization and distribution in normal rectal tissue and LARC.<br /><br><br /><br>Secondary study parameter for endoscopy part:<br /><br>- Histological information and in vivo cellular detection of the fluorescent<br /><br>tracer cetuximab-IRDye800CW (CLE; optionally);</p><br>