NL-OMON40163
Withdrawn
Not Applicable
Visualization of a VEGF-targeted Near-Infrared Fluorescent Tracer in patients with Familial Adenomatous Polyposis during Fluorescence Endoscopy. A single center pilot intervention study - FAP Fluorescence Endoscopy Study
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 15
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •\* 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.
Investigators
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