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Phase 2 Completed N=44 Diagnostic

Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

Source: ClinicalTrials.gov NCT00543777 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Overall Image Quality of Magnetic Resonance Elastography (MRE)

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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