Image Guided Surgery in Sinonasal Inverted Papilloma
- Sponsor
- University Medical Center Groningen
- Study ID
- NCT03925285
- Phase
- PHASE1
- Status
- Unknown
Conditions
- Inverted Papilloma
- Molecular Fluorescence Imaging
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab-800CW — DRUGTwo to four days prior to surgery bevacizumab-800CW will be administered intravenously
Study Details
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.
Key Dates
- First listed
- Apr 24, 2019
- Start date
- May 6, 2019
- Status verified
- Apr 2021
- Primary completion
- Jul 1, 2021
- Completion
- Jan 1, 2022
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: IV fluorescent tracer bevacizumab-800CWPatients will be administered with 10 or 25 bevacizumab-800CW.
Primary Outcome Measure
Tumor-to-background ratio of mean fluorescence intensity [ Time Frame: Up to day 4 ]