In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy

Официальное название

In Vivo Imaging of Olfactory Epithelium in Humans With Olfactory Impairment Using Confocal Laser Endomicroscopy

Обзор

This research is being done to better characterize the part of the nose that helps us smell. Currently, the only ways to study smell loss mostly rely on how people report it, rather than being able to see the underlying structures directly. In this study, we will use a special microscope (Confocal Laser Endomicroscopy (CLE)), originally developed for brain tissue, to look at the part of the nose that helps to detects smell. We hope to identify the tiny structures in that area and see how they might be different in people who have smell loss compared to those who do not.

Подробное описание

Aim 1: Evaluate the feasibility of in vivo CLE imaging of the olfactory cleft and nasal turbinate and determine whether CLE features correlate with validated psychophysical olfactory testing and patient-reported quality-of-life measures.

We will obtain preoperative Sniffin' Sticks threshold-discrimination-identification (TDI) scores and questionnaires in 36 surgical patients recruited from NH and VT, followed by intraoperative CLE imaging after intravenous fluorescein. CLE images will be assessed for epithelial features such as neuronal loss, epithelial thinning, basement membrane irregularity, and inflammatory changes.

Aim 2: Compare in vivo CLE imaging features with histopathologic findings from superior turbinate tissue, when available, to identify candidate in vivo imaging biomarkers. When routine surgery includes removal of superior turbinate tissue, CLE images will be paired with histopathology to assess concordance in features such as neuronal density, sustentacular cell integrity, and inflammation.

Вмешательства

• Устройство CONVIVO system
  Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Following image acquisition, a pathologist present in the operating room, will review and capture each image.
• Другое Conventional histologic evaluation
  Following image acquisition, if clinically indicated, the tissue region imaged with the CONVIVO system will then be biopsied. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.
• Препарат Fluorescein injection, USP 10%
  Sodium fluorescein will be administered intravenously or topically (applied directly to nasal mucosa) at doses of 5-10 mg/kg (not exceeding 20 mg/kg cumulative). Administration will be performed by the anesthesia team in the operating room.

Первичные конечные точки

• Evaluate the feasibility of in vivo CLE imaging of the olfactory cleft and nasal turbinate and determine whether CLE features correlate with validated psychophysical olfactory testing and patient-reported quality-of-life measures. [Срок оценки: On day of Surgery, Day 0]

Вторичные конечные точки (1)

• Compare in vivo CLE imaging features with histopathologic findings from superior turbinate tissue, when available, to identify candidate in vivo imaging biomarkers. [Срок оценки: On day of Surgery, Day 0]

Критерии участия

Критерии включения

• Adults aged ≥18 years
• Undergoing endoscopic sinus or endonasal skull base surgery while under - general anesthesia where the nasal turbinate is accessible
• Able to complete study questionnaires and psychophysical smell testing
• Able to provide informed consent.

Критерии исключения

• Known allergy or hypersensitivity to fluorescein
• Pregnancy
• Medical instability precluding participation
• Severe anatomic obstruction preventing safe access to the olfactory cleft and nasal turbinate
• Any other safety concern identified by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Dartmouth-Hitchcock Medical Center — Lebanon

Идентификаторы

NCT: NCT07546617 · STUDY02003356 · UM1TR004772

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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