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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA249765-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| Duke University | OTHER |
| University of Wisconsin, Madison | OTHER |
| National Cancer Institute (NCI) |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of HCC | 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. | Within 6 months after initial index imaging (MRI & US) |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating tumor DNA (ctDNA) | Within 1 year of blood processing | |
| Serum AFP | Serum Alpha-Fetoprotein | Within 1 year of blood processing |
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Inclusion Criteria
Exclusion Criteria
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Patients with diagnosed liver cirrhosis enrolled in imaging-based screening for HCC.
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| Name | Affiliation | Role |
|---|---|---|
| Bachir Taouli | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41665498 | Derived | Lewis S, Wildman-Tobriner B, Cuevas J, Calle S, Bolger I, Wang K, Joshi H, Mankowski Gettle L, Yang JD, Min JH, Sirlin CB, Reeder SB, Bashir MR, Taouli B. Quality of Gadoxetate-enhanced MRI versus US during Hepatocellular Carcinoma Screening in Participants with Cirrhosis. Radiology. 2026 Feb;318(2):e251497. doi: 10.1148/radiol.251497. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| NIH |
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Blood will be collected to measure AFP, AFP-L3 and DCP (Des-carboxy-prothrombin), ctDNA and other tumor markers. The research team will not perform whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) as part of this study.
| Cost-effectiveness | The cost-effectiveness will be assessed using a micro simulation model. | Within 1 year after initial index imaging (MRI & US). |
| New York |
| New York |
| 10029 |
| United States |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |