Trial Outcomes & Findings for Single Breath Hold Abdominal MRI (NCT NCT02434471)

Last Updated: 2018-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

During MRI, up to 60 minutes

Results posted on

2018-07-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Conventional Breath-held LAVA Then Respiratory Triggered Exams 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
Overall Study STARTED	34
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional Breath-held LAVA Then Respiratory Triggered Exams 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
Overall Study Physician Decision	9

Baseline Characteristics

Single Breath Hold Abdominal MRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=25 Participants All study subjects
Age, Continuous	57.94 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: During MRI, up to 60 minutes

Population: The same 25 subjects were used in both groups.

Outcome measures

Outcome measures
Measure	Breath Hold Liver Acquisition With Volume Acquisition (LAVA) n=25 Participants Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.	Respiratory-triggered T1w DISCO LAVA n=25 Participants 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
Motion Artifact Scores	1.8 scores on a scale Standard Deviation 1.0	2.4 scores on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: During MRI, up to 60 minutes

Population: The same 25 subjects were used for each group.

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.

Outcome measures

Outcome measures
Measure	Breath Hold Liver Acquisition With Volume Acquisition (LAVA) n=25 Participants Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care.	Respiratory-triggered T1w DISCO LAVA n=25 Participants 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
Noise Scores	1.7 scores on a scale Standard Deviation 0.6	1.8 scores on a scale Standard Deviation 0.7

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mustafa R. Bashir, M.D.

Duke University

Phone: 919-684-7366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place