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NCT02434471

Single Breath Hold Abdominal MRI

Completed NA Results posted Last updated 2 July 2018
What this trial tests

NA trial testing Respiratory-triggered T1w DISCO LAVA in Abdominal MRI in 54 participants. Completed in 1 June 2017.

Timeline
12 January 2016
Primary endpoint
1 June 2017
1 June 2017

Quick facts

Lead sponsorDuke University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposeother
Enrollment54
Start date12 January 2016
Primary completion1 June 2017
Estimated completion1 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

18 and older, any sex, with Abdominal MRI. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Motion Artifact Scores Primary · 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.

GroupValue95% CI
Breath Hold Liver Acquisition With Volume Acquisition (LAVA)1.8± 1.0
Respiratory-triggered T1w DISCO LAVA2.4± 0.9
Noise Scores Primary · 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.

GroupValue95% CI
Breath Hold Liver Acquisition With Volume Acquisition (LAVA)1.7± 0.6
Respiratory-triggered T1w DISCO LAVA1.8± 0.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Duke University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02434471.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing