Image Guided Surgery in Sinonasal Inverted Papilloma

NCT03925285 | Unknown Phase 1

• 1 other identifier: NL66969.042.18
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inverted Papilloma; Molecular Fluorescence Imaging

Outcome Measures

Primary Outcomes (1)

• Tumor-to-background ratio of mean fluorescence intensity

  Up to day 4

Secondary Outcomes (2)

• Histopathologic assessment (H&E staining) of surgical specimen

  Approximately two weeks

• VEGF immunohistochemistry of surgical specimen

  Approximately two weeks

Study Arms (1)

IV fluorescent tracer bevacizumab-800CW

EXPERIMENTAL

Patients will be administered with 10 or 25 bevacizumab-800CW.

Drug: Bevacizumab-800CW

Interventions

Bevacizumab-800CW DRUG

Two to four days prior to surgery bevacizumab-800CW will be administered intravenously

Also known as: Bevacizumab-IRDye800CW

IV fluorescent tracer bevacizumab-800CW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Vonk 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 DERIVED

MeSH Terms

Conditions

Papilloma, Inverted

Condition Hierarchy (Ancestors)

Papilloma; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients are administered with bevacizumab-800CW. 2-4 days later, fluorescence imaging will be performed peroperatively

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: April 24, 2019
• Study Start: May 6, 2019
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)