Image Guided Surgery in Sinonasal Inverted Papilloma (SNIPER)
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|ClinicalTrials.gov Identifier: NCT03925285|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : May 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Inverted Papilloma Molecular Fluorescence Imaging||Drug: Bevacizumab-800CW||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients are administered with bevacizumab-800CW. 2-4 days later, fluorescence imaging will be performed peroperatively|
|Masking:||None (Open Label)|
|Official Title:||Image Guided Surgery in Sinonasal Inverted Papilloma by Targeting Vascular Endothelial Growth Factor|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: IV fluorescent tracer bevacizumab-800CW
Patients will be administered with 10 or 25 bevacizumab-800CW.
Two to four days prior to surgery bevacizumab-800CW will be administered intravenously
Other Name: Bevacizumab-IRDye800CW
- Tumor-to-background ratio of mean fluorescence intensity [ Time Frame: Up to day 4 ]
- Histopathologic assessment (H&E staining) of surgical specimen [ Time Frame: Approximately two weeks ]Fluorescence signal will be correlated to histology of tissue (inverted papilloma, inflammation, malignant tumor, healthy tissue).
- VEGF immunohistochemistry of surgical specimen [ Time Frame: Approximately two weeks ]VEGF immunohistochemistry to correlate fluorescence signal with VEGF quantities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925285
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 GZ|