benign sinonasal tumor inverted papilloma
Conditions
Interventions
Patients will - after written informed consent - receive an intravenous
injection of the fluorescent tracer. Two to four days later, the fluorescence
guided surgery will be performed using a combina
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Macroscopic fluorescent signal levels (TBR) and tracer distribution observed by NIR fluorescence imaging using the intraoperative multispectral F2 camera system as well as the ex vivo back-table imaging; - Macroscopic and real-time quantification of the fluorescent signal observed by means of the MDSFR/SFF spectroscopy probe (M/m3); - Standard histopathological assessment (i.e. hematoxylin and eosin staining) to correlate fluorescent and non-fluorescent areas detected in vivo with histology using in vivo obtained biopsies and surgical specimen; - VEGF expression by means of VEGF immunohistochemistry; | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient characteristics (age, sex, BMI, history and morbidity, localization and extent of SNIP, treatment outcome, blood pressure, pulse and temperature before and after tracer administration, baseline blood count/liver and kidney function, signs and symptoms before and after tracer administration); - Surgical specimen histopathologic characteristics; - Histopathologic examinations related to ex vivo VEGF expression and bevacizumab-IRDye800CW distribution. | — |
Countries
Netherlands
Outcome results
None listed