Global Longitudinal Assessment of <scp>MASLD</scp> Using Magnetic Resonance Elastography ( <scp>GOLDMINE</scp> ): A Multi‐Center, International Prospective Cohort Study of Imaging Biomarkers in <scp>MASLD</scp> Clinical Outcomes
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.
Authors
- Egbert Madamba (ORCID: https://orcid.org/0000-0002-4065-3538)
- Meagan Gray (ORCID: https://orcid.org/0000-0001-7556-8985)
- Lisa Richards
- Maral Amangurbanova (ORCID: https://orcid.org/0000-0002-3799-3857)
- Souvik Sarkar (ORCID: https://orcid.org/0000-0002-9358-4257)
- Claude B. Sirlin (ORCID: https://orcid.org/0000-0002-6639-9072)
- Veeral Ajmera (ORCID: https://orcid.org/0000-0001-5626-0942)
- Winston Dunn (ORCID: https://orcid.org/0000-0002-4246-6998)
- Kento Imajo (ORCID: https://orcid.org/0000-0002-1931-6326)
- Suzanne R. Sharpton (ORCID: https://orcid.org/0000-0001-7722-5716)
- Cyrielle Caussy (ORCID: https://orcid.org/0000-0001-8089-2907)
- Raj Vuppalanchi (ORCID: https://orcid.org/0000-0003-0637-1577)
- Jonathan G. Stine (ORCID: https://orcid.org/0000-0002-3352-6928)
- Kay Pepin (ORCID: https://orcid.org/0000-0002-8012-8201)
- Rohit Seth Loomba (ORCID: https://orcid.org/0000-0002-4845-9991)
- Kaleb Tesfai (ORCID: https://orcid.org/0000-0001-5968-2294)
- Dina Halegoua‐DeMarzio
- Mark A. Valasek (ORCID: https://orcid.org/0000-0003-1721-3451)
- Monica A. Tincopa (ORCID: https://orcid.org/0000-0002-9954-8548)
- Jaideep Behari (ORCID: https://orcid.org/0000-0001-8077-5137)
- Arpan Mohanty (ORCID: https://orcid.org/0000-0002-8408-8075)
- Ricki Bettencourt (ORCID: https://orcid.org/0000-0001-6267-1078)
- Michael S. Middleton (ORCID: https://orcid.org/0000-0002-4247-1287)
- Michael Fuchs (ORCID: https://orcid.org/0000-0002-5557-682X)
- Bilal Hameed (ORCID: https://orcid.org/0000-0003-2200-8428)
- C Behling
- Richard L. Ehman (ORCID: https://orcid.org/0000-0001-7041-5074)
- Yuji Ogawa
- Luis Antonio Diaz
- Daniel Q. Huang
- Seema Singh
- Atsushi Nakajima (ORCID: https://orcid.org/0009-0006-6795-8581)
- Manuel Rodriguez
- Jerome Boursier
- Mary Dalupang
- Lars Hansen
- Andre DeLeon
- Rohit Puskoor
- Maya Balakrishnan
- Cynthia Miller
Institutions
- Boston University (US)
- New York City Health and Hospitals Corporation (US)
- Mayo Clinic (US)
- Thomas Jefferson University (US)
- Pontificia Universidad Católica de Chile (CL)
- National University of Singapore (SG)
- University of California, San Francisco (US)
- Baylor College of Medicine (US)
- Virginia Commonwealth University (US)
- The University of Kansas Health System (US)
- Florida Gateway College (US)
- University of Alabama at Birmingham (US)
- University of Massachusetts Boston (US)
- University of California San Diego (US)
- Queens Hospital Center (US)
- Hospices Civils de Lyon (FR)
- Mount Sinai Hospital (US)
- Centre Hospitalier Universitaire d'Angers (FR)
- Hôpital Lyon Sud (FR)
- Pinnacle Clinical Research (US)
- University of Minnesota Rochester (US)
- University of Pittsburgh Medical Center (US)
- AstraZeneca (Finland) (FI)
- AstraZeneca (Spain) (ES)
- Indiana University School of Medicine
- Indiana University – Purdue University Indianapolis (US)
- University of California, Davis (US)
- Yokohama City University (JP)
- Vanderbilt University Medical Center (US)
Publication Details
- Journal
- Alimentary Pharmacology & Therapeutics
- Published
- 2026-04-22
- DOI
- https://doi.org/10.1111/apt.70696
- Citations
- 1
- Primary Topic
- Parathyroid Disorders and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 18.60
Funders
- AstraZeneca