familial adenomatous polyposis FAP
Conditions
Interventions
Patients with FAP will receive an intravenous injection with the VEGF-targeting
fluorescent tracer bevacizumab-IRDye800CW. Three days after tracer
administration, patients will undergo the endoscopy
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients with genetically or clinically proven Familial Adenomatous Polyposis (Genetically proven: APC-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis). ;* Age 18 to 70 years. ;* Written informed consent. ;* Adequate potential for follow-up.
Exclusion criteria
Exclusion criteria: * Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. ;* Proctocolectomy.;* MutYH mutation;* Concurrent uncontrolled medical conditions. ;* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause. * History of infusion reactions to bevacizumab or other monoclonal antibody therapies. * Received an investigational drug within 30 days prior to intravenous administration of bevacizumab-800CW. * Inadequately controlled hypertension with or without current antihypertensive medications. * Had within 6 months prior to enrollment: MI, TIA, CVA, pulmonary embolism, uncontrolled CHF, significant liver disease, unstable angina. * Patients receiving anticoagulant therapy with vitamin K antagonists. * Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Evidence of QT prolongation on pretreatment ECG (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to determine the sensitivity of the fluorescent tracer bevacizumab-IRDye800CW using a flexible NIR fluorescence endoscope in identifying adenomatous polyps during surveillance endoscopy in patients with FAP. The (semi-quantitative) fluorescent signal intensity observed by flexible NIR fluorescence endoscopy will be correlated to the VEGF expression in resected adenomas and biopsy specimens and furthermore in situ quantified with the use of the spectroscopy probe. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To (semi)quantify the in vivo NIR fluorescent signal of bevacizumab-IRDye800CW using the NIR fluorescence fiber bundle and spectroscopy probe and to compare this to the ex vivo VEGF levels in adenomas (immunohistochemistry, RNA and DNA analysis). - To (semi)quantify the in vivo NIR fluorescent signal of bevacizumab-IRDye800CW using the optoacoustic endoscope and to compare this to the ex vivo VEGF levels in adenomas (immunohistochemistry, RNA and DNA analysis). - To assess the (sub-)cellular location of bevacizumab-IRDye800CW microscopically - Number of adverse and serious adverse events. | — |
Countries
Netherlands
Outcome results
None listed