Phase 2
N=44
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00543777 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Overall Image Quality of Magnetic Resonance Elastography (MRE)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Magnetic Resonance Elastogram (Diagnostic_test); 2-Point Dixon Magnetic Resonance Imaging (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Image Quality of Magnetic Resonance Elastography (MRE) |
— | — |
| SECONDARY Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis |
— | — |
| SECONDARY Hepatic Steatosis |
22; 5.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Claustrophobia
- Contraindications for MRI
- Unable to hold a breath
- Ascites or other clinical or radiographical signs of portal hypertension
Data sourced from ClinicalTrials.gov (NCT00543777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.