Trial Outcomes & Findings for Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease (NCT NCT00543777)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

44 participants

Primary outcome timeframe

2 Years

Results posted on

2021-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	MRE + 2PD MRI MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue. Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRE + 2PD MRI n=44 Participants MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue. Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
Age, Continuous	47 years n=44 Participants
Sex: Female, Male Female	17 Participants n=44 Participants
Sex: Female, Male Male	27 Participants n=44 Participants
Region of Enrollment United States	44 participants n=44 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: MRE Data processing not conducted, therefore data could not be generated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of trial, up to 2 years

Population: Association between degrees of stiffness measured by MRE in kPa and histopathological grades of fibrosis and steatohepatitis processing not conducted, therefore data could not generated.

Assessed using Pearson correlation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to the end of the trial, up to 2 years

Population: Participants analyzed are those with liver tumors requiring hepatic resection.

Development of a non-invasive means to quantify hepatic steatosis using 2-Point Dixon technique for patients with \>30% steatosis compared to participants with \<30% steatosis. The degree of steatosis was quantified by percent fat fraction (%FF).

Outcome measures

Outcome measures
Measure	MRE + 2PD MRI n=28 Participants MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue. Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
Hepatic Steatosis >30% Steatosis	22 percentage of fat fraction Standard Deviation 5.2
Hepatic Steatosis <30% Steatosis	5.0 percentage of fat fraction Standard Deviation 2.1

Adverse Events

MRE + 2PD MRI

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

Haesun Choi, MD/Professor, Abdominal Imaging Department

UT MD Anderson Cancer Center

Phone: (713) 745-4693

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place