Loading clinical trials...

COMPLETEDPHASE1

Imaging Lung Function Using Oxygen Enhanced MRI

A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent

NCT01731015•Hal C Charles

View on ClinicalTrials.gov

Summary

The goal of this study is to perform a pilot study to evaluate the utilization of oxygen as an inhaled contrast agent to image the airway spaces in normal and diseased human lungs to allow an effect size estimate to power future studies.

Detailed Description

This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air. Objectives * To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent. * To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects must be ≥ 18 years of age;
•2. Evidence of lung disease or injury by medical history, physical exam, and/or clinical laboratories;
•* COPD
•* Asthma
•* Pre/Post Lung Transplant
•* Cystic Fibrosis
•* Emphysema/Other Small Airways Diseases
•* Lung Transplant
•3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
•4. Subjects who are willing and able to comply with scheduled visits and other trial procedures.
+5 more criteria

Exclusion Criteria

•Subjects presenting with any of the following will not be included in the trial:
•1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
•2. Unable to receive 100% oxygen by breathing because of potential hypercapnia ( SpO2 \<90% or FEV1 \< 1 L);
•3. Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
•4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial. This determination is made by the referring physician based on standard clinical practice.
•5. Female; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan.
•Subjects presenting with any of the following will not be included in the trial:
•1. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
•2. Unable to receive 100% oxygen by breathing because of potential hypercapnia (SpO2 \<90% or FEV1 \< 1 L) (Note, we consider this highly unlikely in a 'normal' subject);
•3. Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
+2 more criteria

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

August 22, 2014

Enrollment

ACTUAL participants

Conditions

COPDAsthmaCystic FibrosisEmphysemaSmall Airways Disease

Interventions

Medical Grade Oxygen

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Imaging Lung Function Using Oxygen Enhanced MRI

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Natural History of Noncirrhotic Portal Hypertension

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong