A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation
- 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.
- To compare the positive predictive value (PPV) of CT scan to that of MRI for diagnosing
- 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)
- 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
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)
Within 90 Days Before Transplantation
Christoph Wald, MD, PhD
Lahey Clinic Medical Center - Burlington
United States: NCI
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Lahey Clinic Medical Center - Burlington||Burlington, Massachusetts 01805|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|