Rectal cancer
Conditions
Interventions
Tracer administration: the EGFR-targeted fluorescent tracer
cetuximab-IRDye800CW will be administered intravenously 3 days prior to the
endoscopy/surgery procedure at the UMCG. Afterwards patients w
optionally) may be
performed to obtain in vivo histological information of suspicious lesions.
Additionally, biopsies will be taken from the tumor (max. 8), from normal
tissue (max. 4) and from add
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General main study parameter: - Evaluating vital parameters, ECG, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) for safety assessment; Main study parameter for endoscopy part: - Macroscopic fluorescent signal levels (tumor-to-background ratio) observed by NIR fluorescence imaging correlated to histology between tumor and normal rectal tissue. Main study parameter for surgical part: - Macroscopic fluorescent signal levels (tumor-to-background ratio) observed by NIR fluorescence imaging correlated to histology for resection margins. | — |
Secondary
| Measure | Time frame |
|---|---|
| General secondary study parameters: - Quantification of fluorescence through analyses of spectroscopy measurements; - Fluorescence distribution on a microscopic level for assessment of tracer localization and distribution in normal rectal tissue and LARC. Secondary study parameter for endoscopy part: - Histological information and in vivo cellular detection of the fluorescent tracer cetuximab-IRDye800CW (CLE; optionally); | — |
Countries
Netherlands
Outcome results
None listed