[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06703450":3,"trial-entities:NCT06703450":86,"trial-summary:NCT06703450":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":67,"locations":70,"central_contacts":79,"overall_officials":80,"references":84,"see_also_links":85},"NCT06703450","GCO 23-0855","Guerbet Liver Fibrosis","Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)","ENROLLING_BY_INVITATION","2026-10-01","2026-04","2026-04-21","2024-02-28","Icahn School of Medicine at Mount Sinai","OTHER",false,"The goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with MR elastography, T1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (MASH).","Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as nonalcoholic fatty liver disease or NAFLD) is characterized by the accumulation of excess fat in the liver, ranging from mild forms like non-alcoholic fatty liver (NAFL) to more severe stages such as metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) with associated inflammation, ballooning, fibrosis, and cirrhosis. The severity of MASH and increasing fibrosis stages is associated with higher morbidity and mortality rates. The study will compare dynamic contrast-enhanced (DCE)-MRI measurements of perfusion using gadopiclenol for diagnosis of liver fibrosis to MR elastography and transient elastography, T1 mapping, ultrasound elastography and blood tests, using histopathology as the reference in patients with MASH. In this study, the value of DCE-MRI and texture analysis using gadopiclenol, a new macrocyclic, non-ionic, extracellular contrast agent with high relaxivity will also be assessed which provides, at a lower dose, better contrast-to-noise ratio than gadoterate, gadobenate, and gadobutrol.",[19],"Metabolic Dysfunction-associated Steatotic Liver Disease",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},50,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Liver Stiffness by MR Elastography","Liver stiffness that is quantitively measured by MR Elastography and correlated with grade of tissue fibrosis from histopathology. Min and Max Scale: 0-20 kilopascals (continuous variable). Higher score indicates poorer health outcomes.","during procedure (MRI)",[34,37,40,43],{"measure":35,"description":36,"timeFrame":32},"Total Liver Flow","Liver Perfusion (DCE MRI) to measure Total liver flow (continuous variable) Max and Min: 0-500 mL\u002Fminute per 100g tissue",{"measure":38,"description":39,"timeFrame":32},"Arterial Fraction of flow","Arterial Fraction of flow - measures and compares the blood flow on both sides of a blockage in the heart's coronary artery to see how much the blockage is affecting blood flow.",{"measure":41,"description":42,"timeFrame":32},"Portal Venous Fraction of flow","Portal Venous Fraction of flow - measures and compares the blood flow on both sides of a blockage in the heart's coronary artery to see how much the blockage is affecting blood flow.",{"measure":44,"description":45,"timeFrame":32},"Distribution volume of contrast","Distribution volume of contrast agent","ALL","18 Years","89 Years",true,{"inclusion":51,"exclusion":56,"raw_text":66},[52,53,54,55],"Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).","Both genders.","Age \\> 18 years.","Any racial\u002Fethnic background.",[57,58,59,60,61,62,63,64,65],"Previous history or current diagnosis of HCC or decompensation.","Contraindications for MRI, including","Medically unstable","Intracranial clips","Metal implants","Suspected or confirmed metal in eyes","Cardiac pacemaker, implanted defibrillator, other implanted electronic device","Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost","Severe claustrophobia","Inclusion Criteria:\n\n* Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).\n* Both genders.\n* Age \\> 18 years.\n* Any racial\u002Fethnic background.\n\nExclusion criteria:\n\n* Previous history or current diagnosis of HCC or decompensation.\n* Contraindications for MRI, including\n\n  * Medically unstable\n  * Intracranial clips\n  * Metal implants\n  * Suspected or confirmed metal in eyes\n  * Cardiac pacemaker, implanted defibrillator, other implanted electronic device\n  * Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost\n  * Severe claustrophobia",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":73,"zip":74,"country":75,"geoPoint":76},"Mount Sinai","New York","10029","United States",{"lat":77,"lon":78},40.71427,-74.00597,[],[81],{"name":82,"affiliation":13,"role":83},"Sara Lewis, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":90},[88,89],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Steatohepatitis",[],{"nct_id":4,"found":15,"summary":22,"prompt_version":22}]