In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy or hypersensitivity to fluorescein
Pregnancy
Medical instability precluding participation
Severe anatomic obstruction preventing safe access to the olfactory cleft and nasal turbinate
Trial population
Adults undergoing endoscopic sinus or endonasal skull base surgery while under general anesthesia where the nasal turbinate is accessible at Dartmouth Hitchcock Medical Center.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
CONVIVO system
DeviceApproximately 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.
Conventional histologic evaluation
Other interventionFollowing 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.
Fluorescein injection, USP 10%
DrugSodium 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Target Group (Patients with Olfactory Complaints)3 interventions
Group B: Control Group3 interventions
Trial outcomes
Primary outcomes
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.
(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.
Time frame
On day of Surgery, Day 0Secondary outcomes
1
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. Expected Outcomes: Identification of CLE features corresponding to gold-standard histopathology, generating preliminary in vivo imaging biomarkers.
Time frame
On day of Surgery, Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov
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