High Resolution Micro OCT Imaging

NCT03256773 | Active Not Recruiting

• 2 other identifiers: F1601250011R01HL116213
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; COPD; PCD - Primary Ciliary Dyskinesia; Covid19; Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Notmal

No lung Disease

Cystic Fibrosis

cystic fibrosis Lung Disease

PCD

Primary Ciliary Dyskinesia

COPD

Chronic Obstructive Lung Disease

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Alabama at Birmingham: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive; Ciliary Motility Disorders; COVID-19; Sinusitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Paranasal Sinus Diseases; Nose Diseases

Study Officials

• Steven M Rowe

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: April 15, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)