High Resolution Micro OCT Imaging

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Sinusitis; Cystic Fibrosis; COPD; PCD - Primary Ciliary Dyskinesia

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Notmal; No lung Disease
Cystic Fibrosis; cystic fibrosis Lung Disease
PCD; Primary Ciliary Dyskinesia
COPD; Chronic Obstructive Lung Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Massachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Steven M Rowe, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Pathologic Processes; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Pancreatic Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Congenital Abnormalities; Nose Diseases; Otorhinolaryngologic Diseases; Abnormalities, Multiple; Paranasal Sinus Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; COVID-19; Pulmonary Disease, Chronic Obstructive; Ciliary Motility Disorders; Cystic Fibrosis; Sinusitis
• Other Study ID Numbers: F160125001; 1R01HL116213 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No