Image Guided Surgery in Sinonasal Inverted Papilloma

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In sinonasal inverted papilloma (SNIP) it is very challenging to discriminate between tumor and surrounding tissue. Local recurrence is a frequent phenomenon as it occurs in 16.5% of the cases. There is need for an instrument that is able to guide the surgeon in removing all tumor tissue, whereas resection of healthy tissue is minimalized.

Molecular fluorescence guided surgery enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between normal mucosa and tumor tissue. The objective of this feasibility study is to determine if the intravenously administered conjugate bevacizumab-IRDye800CW accumulates more in SNIP than in normal sinonasal epithelium.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Bevacizumab; Endothelial Growth Factors

Criteria

Inclusion Criteria:

• Biopsy confirmed diagnosis of SNIP and scheduled to undergo surgical resection;

• Age ≥ 18 years;

• Written informed consent;

• Mentally competent person that is able and willing to comply with study procedures.

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 bevacizumab-IRDye800CW;

• 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;