Journal Article Ahead of print
PubMed: 42017265 DOI: 10.1111/apt.70696
Global Longitudinal Assessment of MASLD Using Magnetic Resonance Elastography (GOLDMINE): A Multi-Center, International Prospective Cohort Study of Imaging Biomarkers in MASLD Clinical Outcomes.
Aliment Pharmacol Ther
Authors: Suzanne Sharpton, Luis Antonio Díaz, Kay Pepin, Maral Amangurbanova, Egbert Madamba, Ricki Bettencourt, Seema Singh, Mark Valasek, Mary Dalupang, Kaleb Tesfai, Michael S Middleton, Cynthia Behling, Winston Dunn, Atsushi Nakajima, Kento Imajo, Yuji Ogawa, Cyrielle Caussy, Dina Halegoua-DeMarzio, Arpan Mohanty, Daniel Q Huang, Michael Fuchs, Bilal Hameed, Jonathan G Stine, Maya Balakrishnan, Meagan Gray, Manuel Rodriguez, Andre DeLeon, Rohit Puskoor, Raj Vuppalanchi, Jaideep Behari, Lars Hansen, Cynthia Miller, Valentina Medici, Souvik Sarkar, Jerome Boursier, Monica Tincopa, Veeral Ajmera, Lisa Richards, Claude B Sirlin, Richard L Ehman, Rohit Loomba
Affiliations
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
- MASLD Research Center, University of California San Diego, La Jolla, California, USA.
- Departamento de Gastroenterología, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
- Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
- Resoundant, Inc. Rochester, Minnesota, USA.
- Icahn School of Medicine at Mount Sinai, NYC Health+Hospitals Queens, New York, New York, USA.
- Department of Radiology, University of California San Diego, La Jolla, California, USA.
- Department of Pediatrics, University of California San Diego, La Jolla, California, USA.
- Division of Gastroenterology, University of Kansas Health System, Kansas City, Kansas, USA.
- Department of Gastroenterology, Yokohama City University, Yokohama, Japan.
- Hospices Civils de Lyon, Département Endocrinologie, Diabète et Nutrition, Hôpital Lyon Sud, Pierre-Bénite, France.
- Division of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
- Division of Gastroenterology, Boston University, Boston, Massachusetts, USA.
- Division of Gastroenterology and Hepatology, National University of Singapore, Singapore, Singapore.
- Central Virginia Veterans Affairs Healthcare System and Virginia Commonwealth University, Richmond, Virginia, USA.
- Division of Gastroenterology, University of California San Francisco, San Francisco, California, USA.
- Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
- Division of Gastroenterology, Baylor College of Medicine, Houston, Texas, USA.
- Division of Gastroenterology and Hepatology, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
- Florida Research Institute, Lakewood Ranch, Florida, USA.
- Pinnacle Clinical Research, San Antonio, Texas, USA.
- Pinnacle Clinical Research, Austin, Texas, USA.
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
- Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
- Clinical Trials Manager, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of California Davis, Sacramento, California, USA.
- Centre Hospitalier Universitaire D'angers, HIFIH Laboratory, SFR ICAT 4208, Angers University France, Angers, France.
- Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
- Department of Epidemiology, University of California San Diego, La Jolla, California, USA.
Abstract
BACKGROUND
Metabolic dysfunction-associated steatotic liver disease (MASLD) exhibits marked heterogeneity in fibrosis progression and liver-related outcomes. Liver biopsy is not feasible for longitudinal risk stratification at scale, creating a need for validated non-invasive biomarkers, particularly imaging biomarkers, that can predict clinically meaningful disease progression and liver-related outcomes.
AIMS
To describe the design and rationale of the GOLDMINE study, established to determine whether non-invasive imaging biomarkers predict MASLD progression and liver-related clinical outcomes.
METHODS
GOLDMINE is an investigator-initiated, multi-centre, international longitudinal cohort enrolling up to 1000 adults with either biopsy-proven MASLD or MASLD cirrhosis across the full fibrosis spectrum. Participants are recruited from 15 sites in the US and 4 international sites (Japan, Singapore and France). At baseline, participants undergo clinical phenotyping, vibration-controlled transient elastography, and advanced magnetic resonance imaging (MRI), including proton-density-fat-fraction and magnetic resonance elastography (MRE). MRI (and biospecimen banking) is repeated at 2-year intervals (years 2 and 4), with annual follow-up visits for up to 10 years. Baseline liver histology is centrally processed, digitized and reviewed by a single expert hepatopathologist; all MRI/MREs are centrally interpreted.
RESULTS
The prespecified clinical outcomes include progression to cirrhosis, clinically significant portal hypertension, major adverse liver-related outcomes (ascites, hepatic encephalopathy, portal hypertensive bleeding, liver transplantation/qualification), hepatocellular carcinoma, major adverse cardiovascular events, and all-cause mortality, with independent central adjudication of all events.
CONCLUSIONS
GOLDMINE establishes a rigorously phenotyped MASLD cohort integrating centralized histology, advanced MRI-based biomarkers, longitudinal biobanking, and adjudicated outcomes, providing a platform to validate imaging and blood-based prognostic biomarkers in MASLD.
MeSH
Fibrosis, Elasticity Imaging Techniques, Multiple Chronic Conditions, Cohort Studies, Biopsy, Liver, Biomarkers, Pharmacology, Histology, Therapeutics, Fatty Liver