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Principal Investigator: Mustafa R. Bashir
Organization: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Fiscal Year: 2024
Award: $799,358
Funding agency: National Cancer Institute
Project Summary
Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States. Recent
North American practice guidelines recommend semi-annual HCC surveillance using ultrasound (US) with or
without serum alpha-fetoprotein (AFP) for cirrhotic and other high-risk patients to permit detection of HCC at an
early stage, enabling effective treatment, and potentially improving survival. However, US suffers from limited
performance in patients with cirrhosis and overweight/obesity, causing the sensitivity of US for early-stage
HCC to be as low as 40%.
We recently conceived and tested a novel abbreviated magnetic resonance imaging (AMRI) exam
including T1-weighted imaging (T1-w) at the hepatobiliary phase post gadoxetic acid injection (HBP-AMRI)
designed to detect HCC in cirrhotic patients with improved accuracy, with only 2 sequences (T1-w HBP at 20
min post injection and T2-w). Our preliminary data suggest that HBP-AMRI provides >80% sensitivity for HCC
detection. Here, we propose a prospective multicenter (composed of the Icahn School of Medicine at Mount
Sinai, University of California, San Diego, University of Wisconsin-Madison and Duke University) study to
assess the performance of HBP-AMRI as a screening modality for early detection of HCC in 820 Americans
with cirrhosis. A complete MRI (which includes dynamic imaging, HBP imaging, and other sequences) will be
disaggregated to reconstruct an HBP-AMRI exam. Using this reconstructed exam, we will test our central
hypothesis that HBP-AMRI is more sensitive and cost-effective than US for HCC detection. We will also assess
the incremental diagnostic value of circulating tumor DNA (ctDNA) and serum AFP.
Specifically, we aim to determine the: 1) diagnostic performance of HBP-AMRI vs. US for HCC
screening in cirrhotic patients. 2) added value of ctDNA and serum AFP for improving HCC detection by HBP-
AMRI or US in cirrhotic patients, 3) cost-effectiveness of HBP-AMRI versus US for HCC screening in cirrhotic
patients. Finally, we will reconstruct a gadoxetic acid-enhanced (Dyn-AMRI) exam from the complete exam for
exploratory analyses of the diagnostic performance of Dyn-AMRI vs HBP-AMRI and US for HCC screening.
Our long-term objective is to validate an accurate and precise method for improving the screening and
surveillance for HCC in patients with cirrhosis, with potential mortality reduction from HCC. The successful
completion of this proposal will help validate a novel screening method comprising HBP-AMRI, possibly
combined with ctDNA.
Terms: <21+ years old><Abbreviations><Abdomen><Acids><Active Follow-up><Address><Adoption><Adult><Adult Human><Affect><Alpha-1-Fetoprotein><Alpha-Fetoglobulin><American><Biological Markers><Blood><Blood Reticuloendothelial System><Blood Serum><CAT scan><CT X Ray><CT Xray><CT imaging><CT scan><California><Cancer Cause><Cancer Etiology><Cancers><Cessation of life><Cirrhosis><Clinical><Computed Tomography><Contrast Agent><Contrast Drugs><Contrast Media><Cost Analyses><Cost Analysis><DNA><Darkness><Data><Death><Deoxyribonucleic Acid><Detection><Diagnostic><Early Diagnosis><Fetuins><Future><Genetic Materials><Hepatobiliary><Hepatocarcinoma><Hepatocellular Carcinoma><Hepatocellular cancer><Hepatoma><Image><Injections><Ionizing Electromagnetic Radiation><Ionizing radiation><Lesion><Liver><Liver Cells Carcinoma><MR Imaging><MR Tomography><MRI><MRIs><Magnetic Resonance Imaging><Malignant Neoplasms><Malignant Tumor><Measures><Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance><Methodology><Methods><Modality><Morbidity><Morbidity - disease rate><NMR Imaging><NMR Tomography><Nodule><Nuclear Magnetic Resonance Imaging><Obesity><Over weight><Overweight><Pathology><Patients><Performance><Phase><Practice Guidelines><Primary carcinoma of the liver cells><Prospective Studies><Proteins><Protocol><Protocols documentation><Radiation-Ionizing Total><Radiopaque Media><Reader><Recommendation><Reference Standards><Risk><Risk Factors><Sensitivity and Specificity><Serum><System><Technology><Testing><Time><Tomodensitometry><United States><Universities><Validation><Wisconsin><X-Ray CAT Scan><X-Ray Computed Tomography><X-Ray Computerized Tomography><Xray CAT scan><Xray Computed Tomography><Xray computerized tomography><Zeugmatography><active followup><adiposity><adulthood><assess cost><bio-markers><biologic marker><biomarker><catscan><chronic hepatic disease><chronic hepatic disorder><chronic liver disease><chronic liver disorder><cirrhotic><clinical practice><computed axial tomography><computer tomography><computerized axial tomography><computerized tomography><contrast enhanced><corpulence><cost><cost assessment><cost effective><cost effectiveness><cost evaluation><design><designing><diagnostic ability><diagnostic capability><diagnostic power><diagnostic utility><diagnostic value><digital><early detection><effective therapy><effective treatment><evaluate cost><examine cost><extracellular><follow up><follow-up><followed up><followup><hepatic body system><hepatic organ system><high risk><imaging><imaging approach><imaging based approach><improved><ionizing output><liquid biopsy><liver carcinoma><malignancy><medical college><medical schools><model-based simulation><models and simulation><mortality><neoplasm/cancer><new approaches><non-contrast CT><noncontrast CT><noncontrast computed tomography><novel><novel approaches><novel strategies><novel strategy><patient population><prospective><school of medicine><screening><screenings><tumor DNA><tumor cell DNA><tumor-specific DNA><ultrasound><validations><α-Fetoproteins>