Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy (ACRIN6690)
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.
Drug: iodinated contrast dye
Drug: motexafin gadolinium
Other: Eovist-enhanced MRI
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
|Official Title:||A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation|
- 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 ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2022|
|Estimated Primary Completion Date:||December 2022 (Final data collection date for primary outcome measure)|
Experimental: Waitlisted with HCC-Exception Points
Participants undergo CT and MRI every 90 days for the trial with iodinated contrast dye and motexafin gadolinium, during liver transplant wait listing. Possible Eovist-enhanced MRI substudy participation
Drug: iodinated contrast dye
iodinated Radiocontrast dye for imaging enhancement
Other Name: iodinated radiographic dyeDrug: motexafin gadolinium
Other Name: XcytrinOther: 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.
- 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 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082224
|United States, Alabama|
|UAB Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington DC, District of Columbia, United States, 20007|
|United States, Massachusetts|
|Lahey Clinic Medical Center - Burlington|
|Burlington, Massachusetts, United States, 01805|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, Missouri|
|Washington University, St. Louis|
|St. Louis, Missouri, United States, 63130|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|The Methodist Hospital for Liver Disease and Transplant|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Christoph Wald, MD, PhD||Lahey Clinic Medical Center - Burlington|