Image guided surgery in sinonasal inverted papilloma by targeting vascular endothelial growth factor

Completed

Conditions: 10027656
benign sinonasal tumor
inverted papilloma

Registration Number: NL-OMON45848

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

- Biopsy confirmed diagnosis of SNIP and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head and Neck Tumor Board of the UMCG;
- Age * 18 years;
- Written informed consent;
- Mentally competent person that is able and willing to comply with study procedures;
- Acceptable hematologic status, kidney function and liver function, as standard surgery protocol requires.

Exclusion Criteria

- Medical or psychiatric conditions that compromise the patient*s ability to give informed consent;
- Concurrent uncontrolled medical conditions;
- Received an investigational drug within 30 days prior to the dose of the fluorescent tracer;
- Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible;
- History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease or unstable angina within 6 months prior to enrollment;
- Inadequately controlled hypertension with or without current antihypertensive medications;
- History of infusion reactions to bevacizumab or other monoclonal antibody therapies;
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause;
- Lab values that in the opinion of the primary surgeon would prevent surgical resection;
- Life expectancy < 12 weeks;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Macroscopic fluorescent signal levels (TBR) and tracer distribution observed<br /><br>by NIR fluorescence imaging using the intraoperative multispectral F2 camera<br /><br>system as well as the ex vivo back-table imaging;<br /><br>- Macroscopic and real-time quantification of the fluorescent signal observed<br /><br>by means of the MDSFR/SFF spectroscopy probe (M/m3);<br /><br>- Standard histopathological assessment (i.e. hematoxylin and eosin staining)<br /><br>to correlate fluorescent and non-fluorescent areas detected in vivo with<br /><br>histology using in vivo obtained biopsies and surgical specimen;<br /><br>- VEGF expression by means of VEGF immunohistochemistry;</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Patient characteristics (age, sex, BMI, history and morbidity, localization<br /><br>and extent of SNIP, treatment outcome, blood pressure, pulse and temperature<br /><br>before and after tracer administration, baseline blood count/liver and kidney<br /><br>function, signs and symptoms before and after tracer administration);<br /><br>- Surgical specimen histopathologic characteristics;<br /><br>- Histopathologic examinations related to ex vivo VEGF expression and<br /><br>bevacizumab-IRDye800CW distribution. </p><br>