Hepatocellular Carcinoma (HCC), Liver Cirrhosis
Conditions
Keywords
Magnetic Resonance Imaging (MRI), Ultrasound (US), Liver Diseases, Elastography
Brief summary
The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. This study will help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.
Detailed description
Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (\ 30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation. This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.
Interventions
None listed
Sponsors
University of California, San Diego
Duke University
University of Wisconsin, Madison
National Cancer Institute (NCI)
Icahn School of Medicine at Mount Sinai
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Liver cirrhosis of any etiology. * 18 years of age and older. * Enrolled in screening/surveillance program for HCC. * Clinically indicated imaging-based screening for HCC. * Willing and able to complete all study procedures within specified time windows. * Patient is able to give informed consent for this study.
Exclusion criteria
* Contra-indications to MRI. * Age less than 18 years. * Patients with chronic renal failure or inability to tolerate contrast. * Inability to undergo MRI due to lack of insurance coverage. * Prior negative screening exam less than 5 months prior to enrollment. * Prior hepatic resection. * Post liver transplantation. * Previously treated HCC or other liver neoplasm. * Any other condition or factor that in judgment of study investigator may interfere with study completion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of HCC | Within 6 months after initial index imaging (MRI & US) | The presence of HCC will be determined by a composite reference standard. This composite reference standard incorporates the results of the complete MRI exam, pathology, and clinical follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating tumor DNA (ctDNA) | Within 1 year of blood processing | — |
| Serum AFP | Within 1 year of blood processing | Serum Alpha-Fetoprotein |
| Cost-effectiveness | Within 1 year after initial index imaging (MRI & US). | The cost-effectiveness will be assessed using a micro simulation model. |
Countries
United States
Outcome results
None listed