Pulmonary DiseaseNCT02862418
Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)
An observational study of Pulmonary Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This research study has 2 purposes: 1. To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as traditional MRI. 2. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- UTE MRI
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Jul 2024
- Phase
- Observational
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults age 5 and older with and without diagnosed pulmonary disease.
Who may be able to join
- Signed informed consent or Parental Permission
- Age ≥ 5 years
- Willing and able to comply with MRI instructions
Who cannot join
- History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
- Standard MRI exclusion criteria as set forth by the Cincinnati Children's Hospital Radiology Department and Imaging Research Center.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Imaging With Ultra-short Echo Time MRI
This research study has 2 purposes:
- To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as traditional MRI.
- To collect images and health information about lungs that have different kinds of lung diseases to compare to healthy lungs. This collection will help researchers and clinicians to better understand lung variations in health and disease.
This study will involve one MRI session that will take about 10 to 30 minutes and for some participants a breathing test that measures how well the lungs are working. This test is called spirometry.
Read the detailed description
Interstitial, obstructive, and rare lung diseases are pulmonary disorders that comprise more than 300 disease entities that are poorly understood, diagnosed, and treated. X-ray computed tomography (CT) is the imaging gold standard and the current clinical practice for imaging lung structure and function of patients. Recent advances in magnetic resonance imaging (MRI) pulse sequences and hardware with ultra short echo times (UTE) have enabled MRI of lung anatomy nearly comparable to CT without the risk of ionizing radiation.
The overreaching goals of this study are:
- to allow for technical development and validation of UTE MRI sequences as an imaging alternative to CT as well as a future diagnostic tool, and
- to allow for preliminary UTE data generation for healthy and various disease populations. We anticipate this as being particularly important for data on children where variability is greater due to normal variations in size, age and maturity as well as distinctive differences in expression of lung diseases in pediatrics versus adult populations.
This is a prospective, controlled study for technical development and validation of UTE MRI techniques with normal and disease cohorts. This study will use the standard MRI hardware (FDA approved coils and magnet) but will be developing and refining techniques used in the MRI sequences to obtain UTE images. This refinement includes varying the MRI settings to maximize image signal, to control image contrast, and to develop the software needed to acquire more specialized images for the purpose of improved imaging of the lungs. The data will also be used to collect normative data for comparison with lung pathologies.
Subjects may enroll more than once (with separate consent). For these subjects the MRI information may be used to generate data for in-subject temporal variability in both healthy controls and disease groups.
- Conditions
- Pulmonary Disease
- Being tested
- UTE MRI
- Keywords
- MRI, UTE MRI, Pulmonary
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UTE MRIOther
One MRI with UTE settings will be acquired.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary disease | UTE MRI Receives: Other: UTE MRI | |
| Control | UTE MRI Receives: Other: UTE MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Anatomic MRI to UTE MRI
UTE MR imaging sequences will be evaluated by a radiologist for image quality and, if applicable, will be compared to anatomic scans acquired with traditional MRI settings
Measured: Day 1 after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startOct 2015
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zackary Cleveland, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862418
- Sponsor's protocol ID
- CIN001-Lung UTE MRI
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2016
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: MRI results may be shared with treating physicians to support clinical decisions if images are felt to have clinical significance.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Imaging With Ultra-short Echo Time MRI
- ClinicalTrials.gov ID
- NCT02862418
- Acronym / sponsor ID
- CIN001-Lung UTE MRI
- Conditions
- Pulmonary Disease
- Keywords
- MRI, UTE MRI, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 11 Aug 2016 (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.
This research study has 2 purposes:
- To learn about new ways to use Magnetic Resonance Imaging (MRI) to take clearer pictures of the lungs. A type of MRI called Ultra Short Echo Time (UTE) will be used as well as traditional MRI.
- To collect images and health information about lungs that have different kinds of lung diseases to compare to healthy lungs. This collection will help researchers and clinicians to better understand lung variations in health and disease.
This study will involve one MRI session that will take about 10 to 30 minutes and for some participants a breathing test that measures how well the lungs are working. This test is called spirometry.
Detailed description
Interstitial, obstructive, and rare lung diseases are pulmonary disorders that comprise more than 300 disease entities that are poorly understood, diagnosed, and treated. X-ray computed tomography (CT) is the imaging gold standard and the current clinical practice for imaging lung structure and function of patients. Recent advances in magnetic resonance imaging (MRI) pulse sequences and hardware with ultra short echo times (UTE) have enabled MRI of lung anatomy nearly comparable to CT without the risk of ionizing radiation.
The overreaching goals of this study are:
- to allow for technical development and validation of UTE MRI sequences as an imaging alternative to CT as well as a future diagnostic tool, and
- to allow for preliminary UTE data generation for healthy and various disease populations. We anticipate this as being particularly important for data on children where variability is greater due to normal variations in size, age and maturity as well as distinctive differences in expression of lung diseases in pediatrics versus adult populations.
This is a prospective, controlled study for technical development and validation of UTE MRI techniques with normal and disease cohorts. This study will use the standard MRI hardware (FDA approved coils and magnet) but will be developing and refining techniques used in the MRI sequences to obtain UTE images. This refinement includes varying the MRI settings to maximize image signal, to control image contrast, and to develop the software needed to acquire more specialized images for the purpose of improved imaging of the lungs. The data will also be used to collect normative data for comparison with lung pathologies.
Subjects may enroll more than once (with separate consent). For these subjects the MRI information may be used to generate data for in-subject temporal variability in both healthy controls and disease groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary disease | – | Other: UTE MRIUTE MRI |
| Control | – | Other: UTE MRIUTE MRI |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults age 5 and older with and without diagnosed pulmonary disease.
Key inclusion criteria (3 listed)
- Signed informed consent or Parental Permission
- Age ≥ 5 years
- Willing and able to comply with MRI instructions
Key exclusion criteria (3 listed)
- History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
- Standard MRI exclusion criteria as set forth by the Cincinnati Children's Hospital Radiology Department and Imaging Research Center.
- Pregnancy
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 |
|---|---|---|
| UTE MRIOne MRI with UTE settings will be acquired. | Other | Control, Pulmonary disease |
Primary outcome
Comparison Anatomic MRI to UTE MRI
Time frame: Day 1 after MRI
UTE MR imaging sequences will be evaluated by a radiologist for image quality and, if applicable, will be compared to anatomic scans acquired with traditional MRI settings
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 7 Jan 2026.
- Individual participant dataSharing planned: Yes. MRI results may be shared with treating physicians to support clinical decisions if images are felt to have clinical significance.
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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.
Zackary Cleveland, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 3 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 7 Jan 2026. 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.
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?
Comparison Anatomic MRI to UTE MRI (time frame: Day 1 after MRI). 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 7 Jan 2026.