High Resolution Micro OCT Imaging

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cystic Fibrosis Abnormalities, Multiple COPD COVID-19 Chronic Disease Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronaviridae Infections Coronavirus Infections Covid19 Digestive System Diseases Disease Attributes Genetic Diseases, Inborn ILD Infant, Newborn, Diseases Infections Lung Diseases Lung Diseases, Obstructive Nidovirales Infections Normal Controls Nose Diseases Otorhinolaryngologic Diseases PCD - Primary Ciliary Dyskinesia Pancreatic Diseases Paranasal Sinus Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Disease, Chronic Obstructive RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sinusitis Virus Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

feasibility of uOCT probe

Time frame: 1 year

to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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)

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Aug 22, 2017
Registry last updated: Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting