Abdominal MRI
Conditions
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.
Interventions
DEVICERespiratory-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
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* undergoing abdominal MRI
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motion Artifact Scores | 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 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All study subjects | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 9 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 57.94 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: During MRI, up to 60 minutes
Population: The same 25 subjects were used in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breath Hold Liver Acquisition With Volume Acquisition (LAVA) | Motion Artifact Scores | 1.8 scores on a scale | Standard Deviation 1 |
| Respiratory-triggered T1w DISCO LAVA | Motion Artifact Scores | 2.4 scores on a scale | Standard Deviation 0.9 |
p-value: <0.001Mixed Models Analysis
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.
Time frame: During MRI, up to 60 minutes
Population: The same 25 subjects were used for each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breath Hold Liver Acquisition With Volume Acquisition (LAVA) | Noise Scores | 1.7 scores on a scale | Standard Deviation 0.6 |
| Respiratory-triggered T1w DISCO LAVA | Noise Scores | 1.8 scores on a scale | Standard Deviation 0.7 |
p-value: 0.83Mixed Models Analysis