High Resolution Micro OCT Imaging

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT03256773

Collaborator

Massachusetts General Hospital (Other)

Enrollment

Location

92.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis COPD PCD - Primary Ciliary Dyskinesia Covid19 Sinusitis

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Apr 15, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Notmal No lung Disease
Cystic Fibrosis cystic fibrosis Lung Disease
PCD Primary Ciliary Dyskinesia
COPD Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

University of Alabama at Birmingham
Massachusetts General Hospital

Investigators

Principal Investigator: Steven M Rowe, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steven M Rowe, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03256773

Other Study ID Numbers:

F160125001

First Posted:

Aug 22, 2017

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sinusitis

Cystic Fibrosis

Ciliary Motility Disorders

Dyskinesias

Study Results

No Results Posted as of Jan 12, 2022