Imaging Lung Function Using Oxygen Enhanced MRI

NCT01731015 | Completed Phase 1

• 2 other identifiers: Pro00024828DIAL1001002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Image Quality

  Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images

  one exposure

Study Arms (2)

Normal Subject

EXPERIMENTAL

Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.

Drug: Medical Grade Oxygen

Subjects with Lung/or Airway Disease

EXPERIMENTAL

Each subject will receive oxygen as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures. The subjects will receive the gas by breathing room air interleaved with oxygen using a standard Douglas Bag system. No additional drug products, investigational or otherwise will be provided in this study.

Drug: Medical Grade Oxygen

Interventions

Medical Grade Oxygen DRUG

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.

Also known as: oxygen

Normal Subject; Subjects with Lung/or Airway Disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be ≥ 18 years of age;
• 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
• 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.

You may not qualify if:

• 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 100% oxygen by breathing because of potential hypercapnia ( SpO2 \<90% or FEV1 \< 1 L);
• 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. This determination is made by the referring physician based on standard clinical practice.
• 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.
• Subjects must be ≥ 18 years of age;
• Non-smokers, ex-smokers with normal pulmonary function test by spirometry;
• 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.
• 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 100% oxygen by breathing because of potential hypercapnia (SpO2 \<90% or FEV1 \< 1 L) (Note, we consider this highly unlikely in a 'normal' subject);
• Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Cystic Fibrosis; Emphysema

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Cecil Charles, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 21, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 22, 2014

Record last verified: 2012-11

Locations

US (1)