Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen

Asthma Clinical Trial

Official title:

Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710449
• Other study ID #: Pro00015170
• Secondary ID: DIAL1001001
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2012
• Last updated: December 5, 2013
• Start date: September 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal controls. Each subject will receive PFP as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.

Description:

The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gas mixed with oxygen as an exogenous inert contrast agent to image the airway spaces in normal and diseased human lungs. This is an open label proof of concept study expanding on work by other groups in animals and ex-vivo human lungs and on studies in human subjects with such gases. Projection images (2-dimensional) and 3D images will be obtained using 19F MRI coupled with spirometry breathing maneuvers to correlate spirometry variables (e.g. FEV1 and FEV1/FVC) with regional distribution of the gas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Subjects with Lung and/or Airway Disease

-Inclusion Criteria

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;

1. COPD

2. Asthma

3. Cystic Fibrosis

4. Emphysema/Other Small Airways Diseases

5. 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

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 gas mixture by breathing because of contraindications;

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.

Normal Subjects

-Inclusion Criteria

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;

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

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 gas mixture by breathing because of contraindications;

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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Drug:
• perfluorinated gas/oxygen mixture
Subjects are imaged with MRI one time in an proof of concept study for the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.

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	MRI image quality of Perfluorinated Gas imaging of the lung	Identify Image quality characteristics related to lung function characterized by 19F MRI.	Single exposure	No