Imaging Regional Lung Defect Severity

NCT01640288 | Completed Phase 1 Results DMC

• 1 other identifier: Pro00037791
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and evaluate the usefulness of magnetic resonance imaging (MRI) using inert perfluorinated gases mixed with oxygen for regional assessment of pulmonary function. The proposed study seeks to determine regional qualitative and quantitative lung function information in the context of the clinical trajectory of chronic obstructive pulmonary disease (COPD) defined by the cross sectional cohort component. In the case of these perfluorinated (PFx)/oxygen mixtures, the availability of multi-liter quantities allows for wash-in/wash-out image acquisition and analysis allowing direct measures of gas trapping in a manner not easily achieved with any existing modality.

Conditions

COPD

Keywords

COPD; Pulmonary Function Testing; MRI; Normal Lung Function; Current Smoker; Non Smoker; Ex Smoker

Outcome Measures

Primary Outcomes (1)

• Gas Trapping Measured During Washout of the Perfluorinated Gas Mixture.

  Determine quantitative measures of lung ventilation performance in terms of direct measures of gas trapping measured during washout of the perfluorinated gas mixture. Measurement of 'gas trapping' was accomplished using fractional lung volume fast and slow filling compartments. Fractional lung volumes are derived from the MRI (lung volume with fast or slow filling/total MR volume elements in the lung field defined by the gas imaging). All data is normalized per subject to the total lung volume of each subject to eliminate bias due to gender, race, age as is required in global pulmonary function tests. Subaim 2: Compare global pulmonary function tests (PFT's) with gas mean wash-in and washout time constants.

  Study Duration: < 1hr for MRI (Magnetic Resonance Imaging), < 1 Hr for HRCT (High Resolution Computed Tomography), < 1 hr for PFT's (Pulmonary Function Tests)

Secondary Outcomes (1)

• Ventilation Defect Severity During wash-in of the Perfluorinated Gas Mixture

  ≤ One hour

Other Outcomes (1)

• Subaim 1.1: Compare Gas Trapping With Air Trapping by HRCT

  < 1hr

Study Arms (2)

Normal Subjects

OTHER

Subjects with Normal Lung Function by Pulmonary Function Tests (e.g. Spirometry) with or without smoking as a risk factor (non-smokers, ex-smokers, current smokers)

Drug: Perfluorinated Gas/Oxygen Mixture; Other: High Resolution CT of the Chest

Subjects with COPD

OTHER

Subjects diagnosed with COPD by GOLD criteria.

Drug: Perfluorinated Gas/Oxygen Mixture; Other: High Resolution CT of the Chest

Interventions

Perfluorinated Gas/Oxygen Mixture DRUG

19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, \< 1 hour

Also known as: Perfluorinated Propane Imaging

Normal Subjects; Subjects with COPD

High Resolution CT of the Chest OTHER

High Resolution CT of the Chest, single visit

Normal Subjects; Subjects with COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients of either gender, age \> 18.
• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
• Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.
• Clinical diagnosis of COPD confirmed by spirometry demonstrating FEV1/FVC \< 0.70

You may not qualify if:

• Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
• Abuse of alcohol or illicit substances
• Medical conditions, which, in the opinion of the investigator, will significantly affect five-year survival.
• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
• Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine, renal insufficiency with epidermal growth factor receptor (eGFR) \< 60 mL/min/1.73 m2)
• Continued therapy with the patient's prescribed COPD regimen will be permitted. Similarly, all other prescribed medications will be allowed.
• Normal Subjects: All subjects will be adults (age \>18) with normal pulmonary function tests (spirometrically confirmed) recruited from the greater Durham, North Carolina community. We anticipate 52% female and 14% minority based on community demographics (see below). No subject will be excluded from the study on the basis of gender or ethnicity. Female subjects of childbearing potential will undergo pregnancy testing at study entry, and before each procedure. Informed consent will be obtained before a subject begins any study.
• Outpatients of either gender, age \> 18.
• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
• Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.
• Normal pulmonary function testing (PFT) determined by spirometry.
• Abuse of alcohol or illicit substances
• Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke Image Analysis Laboratory

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking Cessation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Results Point of Contact

• Title: H. Cecil Charles, Ph.D.
• Organization: Duke University School of Medicine, Department of Radiology

cecil.charles@duke.edu

919-684-7921

Study Officials

• Cecil Charles, PhD

  Duke University Medical Center, Department of Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 13, 2012
• Study Start: January 1, 2013
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2020-06

Locations

US (1)