Clinical study to evaluate the efficacy of the novel driver pad for magnetic resonance elastography

JRCT ID: jRCT1042230108

Registered date:21/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: This study is aimed at adult volunteers.
• Date of first enrollment: 21/11/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Conducting MR elastography using the vibration auxiliary pad.

Outcome(s)

• Primary Outcome: Coherent wave area area in liver MRE wave image

Secondary Outcome

Consistency between with and without vibration assistance pads of liver stiffness measured by liver MRE

Reproducibility of liver stiffness between two liver MRE imaging

Intraobserver agreement, interobserver agreement with/without vibration auxiliary pad

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Men and women over 20 years old

Exclude criteria

Those who are in poor general condition

Women who are pregnant or may be pregnant

Those who require special attention when undergoing an MRI examination (there is a fear of isolation, can not follow breathing instructions, is large and does not enter the MRI gantry, it is difficult to maintain position during the examination due to diseases, etc.)

Those who have internal metal within the imaging range and produce strong artifacts

Related Information

• Primary Sponsor: Goshima Satoshi
• Source(s) of Monetary Support: Hamamatsu University School of Medicine