COPDPhase 1NCT01731015
Imaging Lung Function Using Oxygen Enhanced MRI
A Phase 1 study testing Medical Grade Oxygen in people with COPD and Asthma, run by Hal C Charles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Asthma, Cystic Fibrosis
- What is being tested?
- Medical Grade Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Pre/Post Lung Transplant
Show all 24Show fewer
- 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 for Subjects with Lung and/or Airway Disease:
- 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.
- Inclusion Criteria for Normal Subjects 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, 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.
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent
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.
Read the detailed description
This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air.
Objectives
- To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent.
- To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1
- Conditions
- COPD, Asthma, Cystic Fibrosis, Emphysema, Small Airways Disease
- Being tested
- Medical Grade Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Cystic Fibrosis, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Grade OxygenDrug
Also called oxygen
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Medical Grade Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images
Measured: one exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hal C Charles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hal C Charles, Duke University
- Investigators
- Cecil Charles, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731015
- Sponsor's protocol ID
- Pro00024828
- Other IDs
- DIAL1001002
- Status last verified
- Nov 2012
- First submitted
- 16 Nov 2012
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent
- ClinicalTrials.gov ID
- NCT01731015
- Acronym / sponsor ID
- Pro00024828
- Conditions
- COPD, Asthma, Cystic Fibrosis, Emphysema, Small Airways Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hal C CharlesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open label study expanding on work by other groups in animals, ex-vivo human lungs and human subjects. Both 2-dimensional and 3-dimensional images will be obtained using 1H MRI comparing images obtained while breathing oxygen to those obtained breathing room air.
Objectives
- To determine if 1H magnetic resonance images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung functional information with oxygen as a contrast agent.
- To determine the short term reproducibility of the lung functional imaging in a subset of subjects (5 control subjects and 5 subjects with lung disease) with repeat MRI studies (Visit 2) at a time point ≥ 1 week to ≤ 4 weeks from Visit 1
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Subject | Experimental | Drug: Medical Grade OxygenEach 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. |
| Subjects with Lung/or Airway Disease | Experimental | Drug: Medical Grade OxygenEach 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into 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.
Key exclusion criteria (6 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Grade OxygenAlso: oxygenAt 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. | Drug | Normal Subject, Subjects with Lung/or Airway Disease |
Primary outcome
Image Quality
Time frame: one exposure
Assessment of image quality of oxygen enhanced MR images: Signal to Noise Ratio, Dynamic Range of Ratio/Difference Images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecil Charles, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medical Grade Oxygen in people with COPD and Asthma, run by Hal C Charles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: one exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.