NCT01082224

Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy

A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	iodinated contrast dye	iodinated Radiocontrast dye for imaging enhancement
DRUG	motexafin gadolinium	motexafin gadolinium
OTHER	Eovist-enhanced MRI	A sub-study introduces the Eovist contrast agent for MRI scans at the same time points as the parent policy-assessment trial.

Timeline

• Start date: 2010-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2010-03-08
• Last updated: 2023-07-07

Locations

9 sites across 1 country: United States