Visualization of a VEGF-targeted Near-Infrared Fluorescent Tracer in patients with Familial Adenomatous Polyposis during Fluorescence Endoscopy. A single center pilot intervention study

Withdrawn

• Conditions: familial adenomatous polyposis; FAP; 10017934; 10017987

• Registration Number: NL-OMON40163
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of this study is to determine the sensitivity of the<br /><br>fluorescent tracer bevacizumab-IRDye800CW using a flexible NIR fluorescence<br /><br>endoscope in identifying adenomatous polyps during surveillance endoscopy in<br /><br>patients with FAP. The (semi-quantitative) fluorescent signal intensity<br /><br>observed by flexible NIR fluorescence endoscopy will be correlated to the VEGF<br /><br>expression in resected adenomas and biopsy specimens and furthermore in situ<br /><br>quantified with the use of the spectroscopy probe. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To (semi)quantify the in vivo NIR fluorescent signal of<br /><br>bevacizumab-IRDye800CW using the NIR fluorescence fiber bundle and spectroscopy<br /><br>probe and to compare this to the ex vivo VEGF levels in adenomas<br /><br>(immunohistochemistry, RNA and DNA analysis).<br /><br>- To (semi)quantify the in vivo NIR fluorescent signal of<br /><br>bevacizumab-IRDye800CW using the optoacoustic endoscope and to compare this to<br /><br>the ex vivo VEGF levels in adenomas (immunohistochemistry, RNA and DNA<br /><br>analysis).<br /><br>- To assess the (sub-)cellular location of bevacizumab-IRDye800CW<br /><br>microscopically<br /><br>- Number of adverse and serious adverse events.</p><br>