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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Abdominal MRI
Intervention Device: Respiratory-triggered T1w DISCO LAVA
Enrollment 54
Recruitment Details  
Pre-assignment Details Subjects did not continue participation in the study if their scans were cancelled or rescheduled outside of their hospitalization. Twenty enrolled subjects fell into this category.
Arm/Group Title Conventional Breath-held LAVA Then Respiratory Triggered Exams
Hide Arm/Group Description All study subjects underwent an MRI exam including conventional breath-held LAVA imaging pre- and post-contrast, as well as respiratory-triggered DISCO imaging pre- and post-contrast
Period Title: Overall Study
Started 34
Completed 25
Not Completed 9
Reason Not Completed
Physician Decision             9
Arm/Group Title All Subjects
Hide Arm/Group Description All study subjects
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Participants who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
57.94  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
13
  52.0%
Male
12
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
25
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  24.0%
White
19
  76.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
1.Primary Outcome
Title Motion Artifact Scores
Hide Description 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.
Time Frame During MRI, up to 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The same 25 subjects were used in both groups.
Arm/Group Title Breath Hold Liver Acquisition With Volume Acquisition (LAVA) Respiratory-triggered T1w DISCO LAVA
Hide Arm/Group Description:
Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.

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: 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
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.8  (1.0) 2.4  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Breath Hold Liver Acquisition With Volume Acquisition (LAVA), Respiratory-triggered T1w DISCO LAVA
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Noise Scores
Hide Description 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.
Time Frame During MRI, up to 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
The same 25 subjects were used for each group.
Arm/Group Title Breath Hold Liver Acquisition With Volume Acquisition (LAVA) Respiratory-triggered T1w DISCO LAVA
Hide Arm/Group Description:
Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.

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: 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
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.7  (0.6) 1.8  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Breath Hold Liver Acquisition With Volume Acquisition (LAVA), Respiratory-triggered T1w DISCO LAVA
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Estimation Comments [Not Specified]
Time Frame 60 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description All subjects who completed the study
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   0/25 (0.00%) 
Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mustafa R. Bashir, M.D.
Organization: Duke University
Phone: 919-684-7366
EMail: mustafa.bashir@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02434471    
Other Study ID Numbers: Pro00061735
First Submitted: April 28, 2015
First Posted: May 5, 2015
Results First Submitted: May 1, 2018
Results First Posted: May 31, 2018
Last Update Posted: July 2, 2018