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Image Guided Surgery in Sinonasal Inverted Papilloma (SNIPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925285
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
dr. M.J.H. Witjes, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Inverted Papilloma Molecular Fluorescence Imaging Drug: Bevacizumab-800CW Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: IV fluorescent tracer bevacizumab-800CW
Patients will be administered with 10 or 25 bevacizumab-800CW.
Drug: Bevacizumab-800CW
Two to four days prior to surgery bevacizumab-800CW will be administered intravenously
Other Name: Bevacizumab-IRDye800CW




Primary Outcome Measures :
  1. Tumor-to-background ratio of mean fluorescence intensity [ Time Frame: Up to day 4 ]

Secondary Outcome Measures :
  1. 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).

  2. VEGF immunohistochemistry of surgical specimen [ Time Frame: Approximately two weeks ]
    VEGF immunohistochemistry to correlate fluorescence signal with VEGF quantities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

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


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: dr. M.J.H. Witjes, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03925285    
Other Study ID Numbers: NL66969.042.18
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papilloma
Papilloma, Inverted
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors