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.

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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

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article

Global Longitudinal Assessment of MASLD Using Magnetic Resonance Elastography ( GOLDMINE ): A Multi‐Center, International Prospective Cohort Study of Imaging Biomarkers in MASLD Clinical Outcomes

Egbert Madamba, Meagan Gray, Lisa Richards, Maral Amangurbanova et al.
1 citations
Alimentary Pharmacology & Therapeutics
Parathyroid Disorders and Treatments
18.60
article

Global Longitudinal Assessment of MASLD Using Magnetic Resonance Elastography ( GOLDMINE ): A Multi‐Center, International Prospective Cohort Study of Imaging Biomarkers in MASLD Clinical Outcomes

Egbert Madamba, Meagan Gray, Lisa Richards, Maral Amangurbanova, Souvik Sarkar, Claude B. Sirlin, Veeral Ajmera, Winston Dunn, Kento Imajo, Suzanne R. Sharpton, Cyrielle Caussy, Raj Vuppalanchi, Jonathan G. Stine, Kay Pepin, Rohit Seth Loomba, Kaleb Tesfai, Dina Halegoua‐DeMarzio, Mark A. Valasek, Monica A. Tincopa, Jaideep Behari, Arpan Mohanty, Ricki Bettencourt, Michael S. Middleton, Michael Fuchs, Bilal Hameed, C Behling, Richard L. Ehman, Yuji Ogawa, Luis Antonio Diaz, Daniel Q. Huang, Seema Singh, Atsushi Nakajima, Manuel Rodriguez, Jerome Boursier, Mary Dalupang, Lars Hansen, Andre DeLeon, Rohit Puskoor, Maya Balakrishnan, Cynthia Miller
article en
1 citations

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.

Alimentary Pharmacology & Therapeutics
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)
AstraZeneca
Openalex Percentile: Top 1%
Parathyroid Disorders and Treatments
18.60
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