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Contrast-Enhanced CT Scan and Contrast-Enhanced MRI in Diagnosing and Staging Liver Cancer in Patients With Chronic Liver Disease

2014-08-27 03:15:24 | BioPortfolio

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.

Description

OBJECTIVES:

Primary

- To compare the sensitivity of multiphase contrast-enhanced CT scan to that of multiphase contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC) in patients with chronic liver disease.

Secondary

- To compare the positive predictive value of CT scan to that of MRI for diagnosing HCC.

- To compare the lesion-level sensitivity and positive predictive value of CT scan and MRI as interpreted by radiologists at the respective transplant centers.

- To compare the sensitivity and specificity of 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 positive predictive value are affected by stratifying patients by AFP level (elevated vs normal). (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 Design

Primary Purpose: Diagnostic

Conditions

Liver Cancer

Intervention

iodinated contrast dye, motexafin gadolinium, laboratory biomarker analysis

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:24-0400

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