RATIONALE: Diagnostic procedures, such as contrast-enhanced CT scan and contrast-enhanced MRI, may help find liver cancer and find out how far the disease has spread. PURPOSE: This clinical trial is studying contrast-enhanced CT scan and contrast-enhanced MRI in diagnosing and staging liver cancer in patients with chronic liver disease.
OBJECTIVES: Primary * To compare the sensitivity of multiphase contrast-enhanced CT scan to that of multiphase contrast-enhanced MRI using non-specific contrast agents for diagnosing hepatocellular carcinoma (HCC) in patients with chronic liver disease. Secondary * To compare the positive predictive value (PPV) of CT scan to that of MRI for diagnosing HCC. * To compare the lesion-level sensitivity and PPV of CT scan and MRI as interpreted by radiologists at the respective transplant centers. * To compare the sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC after local ablative therapy in patients listed for liver transplant. * To determine the accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new Organ Procurement and Transplantation Network (OPTN) liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation. * To explore whether the comparisons of sensitivity and PPV are affected by stratifying patients by AFP level (elevated vs normal). (Exploratory) Tertiary * To assess the sensitivity and PPV of MRI and CT interpreted at the participating sites on the basis of all available information and sequences and compare the sensitivity and PPV of the two modalities interpreted using the main study criterion. (Exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to AFP level (elevated vs normal). Patients undergo CT scan with iodinated contrast agent and MRI with extracellular gadolinium contrast agent (both standard-of-care and study-related) at baseline and at 90-day intervals while on the liver transplant wait list. After transplantation, the explanted liver will be analyzed for biomarkers and other studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
440
iodinated Radiocontrast dye for imaging enhancement
motexafin gadolinium
A sub-study introduces the Eovist contrast agent for MRI scans at the same time points as the parent policy-assessment trial.
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)
Time frame: Within 90 Days Before Transplantation
Positive predictive value (PPV) of CT scan vs MRI for diagnosing HCC
Time frame: Within 90 Days Before Transplantation
Lesion-level sensitivity and PPV of contrast CT scan vs contrast MRI
Time frame: Within 90 Days Before Transplantation
Sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC
Time frame: Within 90 Days Before Transplantation
Accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new OPTN liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation
Time frame: Within 90 Days Before Transplantation
Diagnostic value of sensitivity and PPV when patients are stratified by AFP level (elevated vs normal)
Time frame: Within 90 Days Before Transplantation
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Georgetown University Hospital
Washington D.C., District of Columbia, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Washington University, St. Louis
St Louis, Missouri, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Methodist Hospital for Liver Disease and Transplant
Houston, Texas, United States