High Resolution Micro OCT Imaging

Covid19 Clinical Trial

Official title:

Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256773
• Other study ID #: F160125001
• Status: Recruiting
• Start date: April 15, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Heather Hathorne, PhD
• Phone: 205-638-9568
• Email: hhathorne[@]peds.uab.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Description:

Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

THE INCLUSION CRITERIA:

• Patients diagnosed with CF or healthy normal controls with no respiratory disease

• Patients must be over the age of 14

• Patient must be able to give informed consent

THE EXCLUSION CRITERIA:

• Patients with recent respiratory infection requiring antibiotics or corticosteroids in the last 4 weeks (excluding routine perioperative antibiotics)

• Patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares

• Any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room

• Female subjects who are pregnant

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• COPD
• Covid19
• Cystic Fibrosis
• Dyskinesias
• PCD - Primary Ciliary Dyskinesia
• Sinusitis

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of uOCT probe	to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients	1 year