Imaging Lung Function Using Oxygen Enhanced MRI

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731015
• Other study ID #: Pro00024828
• Secondary ID: DIAL1001002
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2012
• Last updated: August 20, 2014
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria for Lung and/or Airway Disease

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

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.

Exclusion Criteria for Subjects with Lung and/or Airway Disease:

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.

Inclusion Criteria for Normal Subjects Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

1. Subjects must be = 18 years of age;

2. Non-smokers, ex-smokers with normal pulmonary function test by spirometry;

3. No Evidence of prior lung disease or lung injury by medical history, physical exam, and/or clinical laboratories;

4. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

5. Subjects who are willing and able to comply with scheduled visits and other trial procedures.

Exclusion Criteria for Normal Subjects

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

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.

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• COPD
• Cystic Fibrosis
• Emphysema
• Pulmonary Disease, Chronic Obstructive
• Small Airways Disease

Intervention

Drug:
• Medical Grade Oxygen
At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hal C Charles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality	Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images	one exposure	No