NCT00543777

Brief Summary

The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called "phase correction algorithm") in patients who might have liver disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 13, 2021

Completed
Last Updated

April 13, 2021

Status Verified

March 1, 2021

Enrollment Period

12.4 years

First QC Date

October 12, 2007

Results QC Date

January 12, 2021

Last Update Submit

March 17, 2021

Conditions

Liver Cancer

Keywords

Liver CancerMagnetic Resonance Elastography2-Point Dixon Magnetic Resonance ImagingLiver DiseaseFatty LiverLiver FibrosisLiver CirrhosisMRE2PD MRIphase correction algorithm

Outcome Measures

Primary Outcomes (1)

  • Overall Image Quality of Magnetic Resonance Elastography (MRE)

    2 Years

Secondary Outcomes (2)

  • Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis

    Baseline to end of trial, up to 2 years

  • Hepatic Steatosis

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

Study Arms (1)

MRE + 2PD MRI

EXPERIMENTAL

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.

Diagnostic Test: Magnetic Resonance ElastogramDiagnostic Test: 2-Point Dixon Magnetic Resonance Imaging

Interventions

Magnetic Resonance ElastogramDIAGNOSTIC_TEST

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.

Also known as: MRE
MRE + 2PD MRI
2-Point Dixon Magnetic Resonance ImagingDIAGNOSTIC_TEST

Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.

Also known as: 2PD MRI
MRE + 2PD MRI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Group 1. Non-oncologic patients from VAMC in Houston:
  • Biopsy proven or clinically suspected advanced parenchymal liver disease
  • Core biopsies obtained within 1-month of MRI/MRE
  • No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy
  • Signed consent
  • Group 2. Oncologic patients at MDACC:
  • Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis, hepatic fibrosis or cirrhosis
  • Surgical or core biopsy scheduled within 4 weeks of MRI/MRE
  • Signed consent

You may not qualify if:

  • Claustrophobia
  • Contraindications for MRI
  • Unable to hold a breath
  • Ascites or other clinical or radiographical signs of portal hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Liver NeoplasmsLiver DiseasesFatty LiverLiver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Haesun Choi, MD/Professor, Abdominal Imaging Department
Organization
UT MD Anderson Cancer Center
hchoi@mdanderson.org
(713) 745-4693

Study Officials

  • Haesun Choi, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 15, 2007

Study Start

September 1, 2007

Primary Completion

January 13, 2020

Study Completion

January 13, 2020

Last Updated

April 13, 2021

Results First Posted

April 13, 2021

Record last verified: 2021-03

Locations

US(1)