Single Breath Hold Abdominal MRI

Abdominal MRI Clinical Trial

Official title:

Single Breath Hold Abdominal MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434471
• Other study ID #: Pro00061735
• Status: Completed
• Phase: N/A
• Start date: January 12, 2016
• Est. completion date: June 1, 2017

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a single breath hold abdominal MRI protocol and compare the image quality of respiratory triggered 3D T1-weighted images against conventional breath hold images.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing abdominal MRI

Exclusion Criteria:

Related Conditions & MeSH terms

• Abdominal MRI

Intervention

Device:
• Respiratory-triggered T1w DISCO LAVA
The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required. Respiratory-triggered T1w DISCO LAVA precontrast Respiratory-triggered T1w DISCO LAVA in the portal venous phase Respiratory-triggered T1w DISCO LAVA in the equilibrium phase

Locations

Country	Name	City	State
United States	DukeUMC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motion Artifact Scores	Three investigators will independently evaluate MRI examinations. They will assign motion scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no motion artifact; 2 = minimal motion artifact, no effect on diagnostic quality; 3 = moderate motion artifact with some, but not severe, effect on diagnostic quality; 4 = severe motion artifact, images degraded but interpretable; and 5 = extensive motion artifact, images nondiagnostic.	During MRI, up to 60 minutes
Primary	Noise Scores	Three investigators will independently evaluate MRI examinations. They will assign noise scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no noise artifact; 2 = minimal noise artifact, no effect on diagnostic quality; 3 = moderate noise artifact with some, but not severe, effect on diagnostic quality; 4 = severe noise artifact, images degraded but interpretable; and 5 = severe noise artifact, images nondiagnostic.	During MRI, up to 60 minutes