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High Resolution Micro OCT Imaging

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ClinicalTrials.gov Identifier: NCT03256773
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : January 12, 2022
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Steven M Rowe, University of Alabama at Birmingham

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
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Study Type : Observational
Estimated 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 : April 15, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256773


Contacts
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Contact: Heather Hathorne, PhD 205-638-9568 hhathorne@peds.uab.edu
Contact: Ginger Reeves, BS 205-638-5970 greeves@peds.uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Heather Hathorne, PhD    205-638-9568    hhathorne@peds.uab.edu   
Contact: Ginger Reeves, BS    205-638-5970    greeves@peds.uab.edu   
Principal Investigator: Rowe Steven, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Massachusetts General Hospital
Investigators
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Principal Investigator: Steven M Rowe University of Alabama at Birmingham
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Steven M Rowe, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03256773    
Other Study ID Numbers: F160125001
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Cystic Fibrosis
Ciliary Motility Disorders
Dyskinesias
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Movement Disorders
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities