Single Breath Hold Abdominal MRI

NCT ID: NCT02434471

Last Updated: 2018-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2017-06-01

Brief Summary

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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

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Conditions

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Abdominal MRI

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Respiratory-triggered T1w DISCO LAVA

Intervention Type 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.

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* undergoing abdominal MRI

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mustafa R Bashir, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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DukeUMC

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00061735

Identifier Type: -

Identifier Source: org_study_id

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