Clinical trial · Interventional
Image Guided Surgery in Sinonasal Inverted Papilloma
Image Guided Surgery in Sinonasal Inverted Papilloma by Targeting Vascular Endothelial Growth Factor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inverted Papilloma | Inverted Papilloma | ONTOLOGY_EXACT | 0.98 |
| Molecular Fluorescence Imaging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab-800CW | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IV fluorescent tracer bevacizumab-800CW
- description
- Patients will be administered with 10 or 25 bevacizumab-800CW.
- interventionNames
- Drug: Bevacizumab-800CW
Primary outcomes (1)
- measure
- Tumor-to-background ratio of mean fluorescence intensity
- timeFrame
- Up to day 4
Secondary outcomes (2)
- measure
- Histopathologic assessment (H&E staining) of surgical specimen
- timeFrame
- Approximately two weeks
- description
- Fluorescence signal will be correlated to histology of tissue (inverted papilloma, inflammation, malignant tumor, healthy tissue).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (1)
- DERIVEDVonk J, Voskuil FJ, de Wit JG, Heeman WT, Nagengast WB, van Dam GM, Feijen RA, Korsten-Meijer A, van der Vegt B, Witjes M. Fluorescence grid analysis for the evaluation of piecemeal surgery in sinonasal inverted papilloma: a proof-of-concept study. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1640-1649. doi: 10.1007/s00259-021-05567-x. Epub 2021 Nov 5. PMID 34738141