Single Breath Hold Abdominal MRI | NCT02434471

Single Breath Hold Abdominal MRI | NCT02434471 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breath hold Liver Acquisition with Volume Acquisition (LAVA)	No Intervention	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	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Respiratory-triggered T1w DISCO LAVA	Device	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 precontrast Respiratory-triggered T1w DISCO LAVA in the portal venous phase Respiratory-triggered T1w DISCO LAVA in the equilibrium phase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	During MRI, up to 60 minutes
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.	During MRI, up to 60 minutes

Contacts/Locations Module

Name	Affiliation	Role
Mustafa R Bashir, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
DukeUMC		Durham	North Carolina	27710	United States

Arm/Group Information

ID	Title	Description
FG000	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

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00034 subjects
COMPLETED		FG00025 subjects
NOT COMPLETED		FG0009 subjects

Type	Comment	Reasons
Physician Decision		FG0009 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	All Subjects	All study subjects

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

The same 25 subjects were used in both groups.

Posted

Mean

Standard Deviation

scores on a scale

During MRI, up to 60 minutes

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All Subjects	All subjects who completed the study	0

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Mustafa R. Bashir, M.D.	Duke University	919-684-7366		mustafa.bashir@duke.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 16, 2015	May 1, 2018	Prot_SAP_000.pdf

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000
Native Hawaiian or Other Pacific Islander	BG0000
Black or African American	BG0006
White	BG00019
More than one race	BG0000
Unknown or Not Reported	BG0000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001		Mean Difference (Final Values)	0.6			2-Sided								Other

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.

The same 25 subjects were used for each group.

Posted

Mean

Standard Deviation

scores on a scale

During MRI, up to 60 minutes

ID	Title	Description
OG000	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.
OG001	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. 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. Respiratory-triggered T1w DISCO LAVA precontrast Respiratory-triggered T1w DISCO LAVA in the portal venous phase Respiratory-triggered T1w DISCO LAVA in the equilibrium phase

Units	Counts
Participants	OG00025 OG00125

Title

Denominators