Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy
NCT ID: NCT01082224
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
440 participants
INTERVENTIONAL
2010-12-31
2023-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
iodinated contrast dye
iodinated Radiocontrast dye for imaging enhancement
motexafin gadolinium
motexafin gadolinium
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.
Interventions
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iodinated contrast dye
iodinated Radiocontrast dye for imaging enhancement
motexafin gadolinium
motexafin gadolinium
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Responsible Party
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Principal Investigators
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Christoph Wald, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lahey Clinic Medical Center - Burlington
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Washington University, St. Louis
St Louis, Missouri, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Methodist Hospital for Liver Disease and Transplant
Houston, Texas, United States
Countries
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References
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Wald C, Nalesnik M, Pomfret EA, et al.: ACRIN 6690: can contemporary imaging reduce false-positive rate in liver transplant (LT) allocation? A multicenter comparison of CT and MRI for diagnosis of hepatocellular carcinoma (HCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS177, 2011.
Mitchell DG, Bruix J, Sherman M, Sirlin CB. LI-RADS (Liver Imaging Reporting and Data System): summary, discussion, and consensus of the LI-RADS Management Working Group and future directions. Hepatology. 2015 Mar;61(3):1056-65. doi: 10.1002/hep.27304. Epub 2014 Dec 12.
Related Links
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ClinicalTrials.gov database
Other Identifiers
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