Respiratory Motion Analysis in Children With MRI

NCT00367354 | Terminated

• 1 other identifier: IRB00041134
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to analyze the respiratory motion process as relevant in cardiac MRI imaging and apply the results for development of improved imaging methods and software correction. To accomplish this, we will develop an imaging protocol for monitoring respiratory motion. The imaging protocol will be limited to less than five minutes of acquisition time so it may be performed as "piggyback" acquisition following clinically prescribed imaging studies on pediatric and adult cardiac MRI patients, but will also be applied to normal healthy volunteers. Hypothesis Characterization of respiratory motion will help improve image quality by allowing optimized scan acquisition and retrospective correction of acquired data.

Conditions

Congenital Disorders

Keywords

Imaging Technology; Cardiology

Outcome Measures

Primary Outcomes (1)

• cardiac motion reduction in cardiac MRI images

  throughout study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.

You may qualify if:

• We will recruit two groups of patients - 35 healthy volunteers (21 years or older) and 25 cardiac MRI patients of different age groups.
• We wish to recruit cardiac patients from Children's Healthcare of Atlanta into five (5) different categories defined by the overall characteristics of breathing motion. The categories are:
• neonates/infants (shallow belly breathing)
• young children (unable to do controlled breathing or breath-holding on command, up to approximately 7 years of age)
• older children capable of controlled breathing/breath-holding on command (approximately 8-12 years of age)
• teenagers/adolescents/young adults (ages 13 through 17)
• adults (18 and older) These categories may be adjusted or modified during the project as deemed appropriate based on the analysis results.
• We will recruit 10 - 35 healthy volunteer subjects for scans to define the MRI imaging protocol for respiratory motion monitoring. Healthy subjects are defined as those individuals who do not have a prior history of heart or lung disease nor are currently diagnosed with heart or lung disease. This information will be obtained verbally during the subject screening process.

You may not qualify if:

• subjects with pacemakers, medical implants, aneurysm clips, or imbedded metal fragments will be excluded because of potential effects of the magnetic field
• women who are pregnant or who may be pregnant will be excluded because of the potential of a high level of RF power deposition on the fetus
• subjects who may experience claustrophobia will be excluded because of their inability to remain in the magnet for the time required to complete the exam

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• William Mahle

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 22, 2006
• Study Start: August 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2011
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)