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

niversitair Medisch Centrum Groningen0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* 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.

•* 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.

发起方