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Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)

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ClinicalTrials.gov Identifier: NCT02862418
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Pulmonary Disease Other: UTE MRI

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:

  1. 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
  2. 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
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lung Imaging With Ultra-short Echo Time MRI
Study Start Date : October 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Pulmonary disease
UTE MRI
 Other: UTE MRI
One MRI with UTE settings will be acquired.
Control
UTE MRI
 Other: UTE MRI
One MRI with UTE settings will be acquired.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and adults age 5 and older with and without diagnosed pulmonary disease.
Criteria

Inclusion Criteria:

  • Signed informed consent or Parental Permission
  • Age ≥ 5 years
  • Willing and able to comply with MRI instructions

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862418


Contacts
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Contact: Erin Watters 513-803-7024 Erin.Watters@cchmc.org
Contact: Laura Walkup, PhD (513)803-4830 Laura.Walkup@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Erin Watters    513-803-7024    Erin.Watters@cchmc.org   
Principal Investigator: Zackary Cleveland, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Zackary Cleveland, PhD Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02862418     History of Changes
Other Study ID Numbers: CIN001-Lung UTE MRI
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: MRI results may be shared with treating physicians to support clinical decisions if images are felt to have clinical significance.

Keywords provided by Children's Hospital Medical Center, Cincinnati:
MRI
UTE MRI
Pulmonary

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases