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

Primary Purpose

COPD, Asthma, Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

perfluorinated gas/oxygen mixture

About this trial

This is an interventional diagnostic trial for COPD focused on measuring Lung Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Subjects must be ≥ 18 years of age;
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
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
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:

Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
Unable to receive gas mixture by breathing because of contraindications;
Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
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.
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:

Subjects must be ≥ 18 years of age;
Non-smokers;
No Evidence of prior lung disease or lung injury by medical history, physical exam, and/or clinical laboratories;
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
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:

Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
Unable to receive gas mixture by breathing because of contraindications;
Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
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.
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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Normal

Lung Disease

Arm Description

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.

Outcomes

Primary Outcome Measures

MRI image quality of Perfluorinated Gas imaging of the lung

Identify Image quality characteristics related to lung function characterized by 19F MRI.

Secondary Outcome Measures

Full Information

NCT ID

NCT01710449

First Posted

October 17, 2012

Last Updated

December 5, 2013

Sponsor

Hal C Charles

1. Study Identification

Unique Protocol Identification Number

NCT01710449

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hal C Charles

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Lung Transplant

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal

Arm Type

Experimental

Arm Description

Arm Title

Lung Disease

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

perfluorinated gas/oxygen mixture

Intervention Description

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.

Primary Outcome Measure Information:

Title

MRI image quality of Perfluorinated Gas imaging of the lung

Description

Identify Image quality characteristics related to lung function characterized by 19F MRI.

Time Frame

Single exposure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Subjects must be ≥ 18 years of age; Evidence of lung disease or injury by medical history, physical exam, and/or clinical laboratories; COPD Asthma Cystic Fibrosis Emphysema/Other Small Airways Diseases Lung Transplant Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. 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: Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia); Unable to receive gas mixture by breathing because of contraindications; Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or 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. 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: Subjects must be ≥ 18 years of age; Non-smokers; No Evidence of prior lung disease or lung injury by medical history, physical exam, and/or clinical laboratories; Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. 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: Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia); Unable to receive gas mixture by breathing because of contraindications; Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cecil Charles, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

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

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