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

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

Study Description

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

• 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

Groups and Cohorts

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

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

• 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

Contacts

Contact: Erin Watters; 513-803-7024; Erin.Watters@cchmc.org

Contact: Laura Walkup, PhD; (513)803-4830; Laura.Walkup@cchmc.org

Locations

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

• Principal Investigator: Zackary Cleveland, PhD; Children's Hospital Medical Center, Cincinnati

More Information

• 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
• 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:

Lung Diseases; Respiratory Tract Diseases