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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03256773

Enrollment

160

Registered

2017-08-22

Start date

2016-04-15

Completion date

2026-12-31

Last updated

2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Covid19, Cystic Fibrosis, ILD, Normal Controls, PCD - Primary Ciliary Dyskinesia, Sinusitis

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSteven M Rowe

University of Alabama at Birmingham

Outcome results