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

NCT ID: NCT01710449

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-10-31

Brief 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.

Detailed 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.

Conditions

COPD; Asthma; Cystic Fibrosis; Emphysema; Small Airways Diseases

Keywords

Lung Transplant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normal

The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.

Group Type: EXPERIMENTAL

perfluorinated gas/oxygen mixture

Intervention Type: DRUG

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.

Lung Disease

The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.

Group Type: EXPERIMENTAL

perfluorinated gas/oxygen mixture

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

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.

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.

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hal C Charles

OTHER

Sponsor Role: lead

Responsible Party

Hal C Charles

Associate Professor Department of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cecil Charles, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

DIAL1001001

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00015170

Identifier Type: -

Identifier Source: org_study_id