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Single Breath Hold Abdominal MRI

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ClinicalTrials.gov Identifier: NCT02434471
Recruitment Status : Completed
First Posted : May 5, 2015
Results First Posted : May 31, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Abdominal MRI Device: Respiratory-triggered T1w DISCO LAVA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Single Breath Hold Abdominal MRI
Actual Study Start Date : January 12, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Arm Intervention/treatment
No Intervention: Breath hold Liver Acquisition with Volume Acquisition (LAVA)
Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.
Active Comparator: 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.
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.

  1. Respiratory-triggered T1w DISCO LAVA precontrast
  2. Respiratory-triggered T1w DISCO LAVA in the portal venous phase
  3. Respiratory-triggered T1w DISCO LAVA in the equilibrium phase




Primary Outcome Measures :
  1. Motion Artifact Scores [ Time Frame: During MRI, up to 60 minutes ]
    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.

  2. Noise Scores [ Time Frame: During MRI, up to 60 minutes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing abdominal MRI

Exclusion Criteria:


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): NCT02434471


Locations
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United States, North Carolina
DukeUMC
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Mustafa R Bashir, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02434471     History of Changes
Other Study ID Numbers: Pro00061735
First Posted: May 5, 2015    Key Record Dates
Results First Posted: May 31, 2018
Last Update Posted: July 2, 2018
Last Verified: May 2018