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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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Medical and Biotech [MESH] Definitions

Iodinated pyridine derivatives that are often used as contrast media.

An iodinated radiographic contrast medium used as acetrizoate sodium in HYSTEROSALPINGOGRAPHY.

Gadolinium. An element of the rare earth family of metals. It has the atomic symbol Gd, atomic number 64, and atomic weight 157.25. Its oxide is used in the control rods of some nuclear reactors.

A complex of gadolinium with a chelating agent, diethylenetriamine penta-acetic acid (DTPA see PENTETIC ACID), that is given to enhance the image in cranial and spinal MRIs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p706)

A chronic, acquired, idiopathic, progressive eruption of the skin that occurs in the context of RENAL FAILURE. It is sometimes accompanied by systemic fibrosis. The pathogenesis seems to be multifactorial, with postulated involvement of circulating fibrocytes. There is a strong association between this disorder and the use of gadolinium-based contrast agents.

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