In Vivo Imaging of Olfactory Epithelium in Humans With Olfactory Impairment Using Confocal Laser Endomicroscopy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
This research is being done to better characterize the part of the nose that helps people 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, the team 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. The study team hopes 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. Participation in the study includes completing a smell test (Sniffin' Sticks Extended test), a cognitive screening test, and two questionnaires.
详细描述
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.
The study team 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Target Group (Patients with Olfactory Complaints)
Patients who have olfactory complaints and are undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible, per their standard of care.
干预措施: CONVIVO system (Device)
Control Group
Controls will consist of surgical patients without subjective olfactory complaints and with expected normal psychophysical testing. Patients who are already undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible, per their standard of care.
干预措施: Fluorescein injection, USP 10% (Drug)
Target Group (Patients with Olfactory Complaints)
Patients who have olfactory complaints and are undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible, per their standard of care.
干预措施: Fluorescein injection, USP 10% (Drug)
Control Group
Controls will consist of surgical patients without subjective olfactory complaints and with expected normal psychophysical testing. Patients who are already undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible, per their standard of care.
干预措施: CONVIVO system (Device)
结局指标
主要结局
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.
时间窗: On day of Surgery, Day 0
(1) High feasibility (≥85% interpretable images); (2) identifiable CLE signatures associated with OD severity; (3) significant correlations between CLE features, TDI scores, and symptom burden.
次要结局
- Compare in vivo CLE imaging features with histopathologic findings from superior turbinate tissue, when available, to identify candidate in vivo imaging biomarkers.(On day of Surgery, Day 0)
研究者
Ryan.E.Little
Director of the Sinus Research Center Assistant Professor of Surgery, Geisel School of Medicine, Dartmouth
Dartmouth-Hitchcock Medical Center