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NCT03925285: SNIPER

Image Guided Surgery in Sinonasal Inverted Papilloma

Status unknown Phase 1 Last updated 3 May 2021
What this trial tests

Phase 1 trial testing Bevacizumab-800CW in Inverted Papilloma in 6 participants. Status unknown.

Timeline
6 May 2019
Primary endpoint
1 July 2021
1 January 2022

Quick facts

Lead sponsorUniversity Medical Center Groningen
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment6
Start date6 May 2019
Primary completion1 July 2021
Estimated completion1 January 2022
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Inverted Papilloma or Molecular Fluorescence Imaging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
    Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
  2. Image-guided surgery and novel intraoperative devices for enhanced visualisation in general and paediatric surgery: a review.
    Privitera L, Paraboschi I, Dixit D, Arthurs OJ, et al · · 2021 · cited 20× · PMID 35937852 · DOI 10.1515/iss-2021-0028
  3. Monoclonal Antibodies for Targeted Fluorescence-Guided Surgery: A Review of Applicability across Multiple Solid Tumors.
    Giuliani S, Paraboschi I, McNair A, Smith M, et al · · 2024 · cited 14× · PMID 38473402 · DOI 10.3390/cancers16051045
  4. Detection by fluorescence of pituitary neuroendocrine tumour (PitNET) tissue during endoscopic transsphenoidal surgery using bevacizumab-800CW (DEPARTURE trial): study protocol for a non-randomised, non-blinded, single centre, feasibility and dose-finding trial.
    Vergeer RA, Postma MR, Schmidt I, Korsten-Meijer AG, et al · · 2021 · cited 6× · PMID 34620658 · DOI 10.1136/bmjopen-2021-049109
  5. Fluorescence grid analysis for the evaluation of piecemeal surgery in sinonasal inverted papilloma: a proof-of-concept study.
    Vonk J, Voskuil FJ, de Wit JG, Heeman WT, et al · · 2022 · cited 3× · PMID 34738141 · DOI 10.1007/s00259-021-05567-x

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Other trials of Bevacizumab-800CW

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