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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

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 5, 2015
Results First Submitted Date  ICMJE May 1, 2018
Results First Posted Date  ICMJE May 31, 2018
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE January 12, 2016
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Motion artifact scores [ Time Frame: During MRI, up to 60 minutes ]
    Two 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
  • Image quality score [ Time Frame: During MRI, up to 60 minutes ]
    Image quality will be graded on a 5-point scale: 5 - excellent 4 - good, clinically acceptable 3 - fair, mild clinical limitations 2 - poor, substantially limited clinically 1 - non-diagnostic
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Breath Hold Abdominal MRI
Official Title  ICMJE Single Breath Hold Abdominal MRI
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Abdominal MRI
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Respiratory-triggered T1w DISCO LAVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
100
Actual Study Completion Date  ICMJE June 1, 2017
Actual Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • undergoing abdominal MRI

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434471
Other Study ID Numbers  ICMJE Pro00061735
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mustafa R Bashir, MD Duke University
PRS Account Duke University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP