Liver Cancer Clinical Trial
Official title:
Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
Verified date | March 2021 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | January 13, 2020 |
Est. primary completion date | January 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Group 1. Non-oncologic patients from VAMC in Houston: 2. Biopsy proven or clinically suspected advanced parenchymal liver disease 3. Core biopsies obtained within 1-month of MRI/MRE 4. No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy 5. Signed consent 6. Group 2. Oncologic patients at MDACC: 7. Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis, hepatic fibrosis or cirrhosis 8. Surgical or core biopsy scheduled within 4 weeks of MRI/MRE 9. Signed consent Exclusion Criteria: 1. Claustrophobia 2. Contraindications for MRI 3. Unable to hold a breath 4. Ascites or other clinical or radiographical signs of portal hypertension |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Image Quality of Magnetic Resonance Elastography (MRE) | 2 Years | ||
Secondary | Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis | Assessed using Pearson correlation | Baseline to end of trial, up to 2 years | |
Secondary | Hepatic Steatosis | 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). | Baseline to the end of the trial, up to 2 years |
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