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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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