Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy
- Conditions
- Liver Cancer
- Interventions
- Registration Number
- NCT01082224
- Lead Sponsor
- American College of Radiology Imaging Network
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 440
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Waitlisted with HCC-Exception Points Eovist-enhanced MRI 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 Waitlisted with HCC-Exception Points iodinated contrast dye 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 Waitlisted with HCC-Exception Points motexafin gadolinium 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
- Primary Outcome Measures
Name Time Method Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC) Within 90 Days Before Transplantation
- Secondary Outcome Measures
Name Time Method Lesion-level sensitivity and PPV of contrast CT scan vs contrast MRI 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 Within 90 Days Before Transplantation Positive predictive value (PPV) of CT scan vs MRI for diagnosing HCC Within 90 Days Before Transplantation Sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC Within 90 Days Before Transplantation Diagnostic value of sensitivity and PPV when patients are stratified by AFP level (elevated vs normal) Within 90 Days Before Transplantation
Related Research Topics
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Trial Locations
- Locations (9)
Lahey Clinic Medical Center - Burlington
🇺🇸Burlington, Massachusetts, 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
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Washington University, St. Louis
🇺🇸Saint Louis, Missouri, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States