[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476640":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":530,"collaborators":23,"id":532,"slug":533,"hasResults":534,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":534,"sex":540,"minAge":541,"maxAge":542,"enrollmentInfo":543,"targetDuration":23,"studyType":546,"phases":547,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":569},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Abdominal Ultrasound Screening with serum AFP","ACTIVE_COMPARATOR","abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8",[13],"Other: Abdominal Ultrasound Screening with serum AFP",{"label":15,"type":16,"description":17,"interventionNames":18},"Abbreviated Magnetic Resonance Imaging with serum AFP","OTHER","Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8",[19],"Other: Abbreviated Magnetic Resonance Imaging with serum AFP",[21,24],{"type":16,"name":15,"description":17,"armGroupLabels":22,"otherNames":23},[15],null,{"type":16,"name":9,"description":11,"armGroupLabels":25,"otherNames":23},[9],[27],{"name":28,"affiliation":29,"role":30},"George N. Ioannou, MD MS","VA Puget Sound Health Care System Seattle Division, Seattle, WA","STUDY_CHAIR",[32],{"name":33,"role":34,"phone":35,"phoneExt":23,"email":36},"George N Ioannou, MD MS","CONTACT","(206) 277-3136","George.Ioannou@va.gov",[38,57,73,87,101,115,128,141,154,169,183,198,214,224,240,255,270,284,298,313,327,342,357,372,387,401,417,431,446,459,474,487,503,516],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Birmingham VA Medical Center, Birmingham, AL","RECRUITING","Birmingham","Alabama","35233-1927","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-86.80249,33.52066,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":23,"email":56},"James Callaway, MD","205-933-8101","James.Callaway@va.gov",{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Southern Arizona VA Health Care System, Tucson, AZ","Tucson","Arizona","85723-0001",{"type":47,"coordinates":63},[64,65],-110.92648,32.22174,{"lat":65,"lon":64},[68],{"name":69,"role":34,"phone":70,"phoneExt":71,"email":72},"Bhupesh Pokhrel, MD","520-792-1450","1-4649","Bhupesh.Pokhrel@va.gov",{"facility":74,"status":40,"city":75,"state":76,"zip":77,"country":44,"countryCode":45,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Central Arkansas Veterans Healthcare System , Little Rock, AR","Little Rock","Arkansas","72205",{"type":47,"coordinates":79},[80,81],-92.28959,34.74648,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":23,"phoneExt":23,"email":86},"Ragesh Thandassery, MD","Ragesh.Thandassery@va.gov",{"facility":88,"status":40,"city":89,"state":90,"zip":91,"country":44,"countryCode":45,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"VA Long Beach Healthcare System, Long Beach, CA","Long Beach","California","90822",{"type":47,"coordinates":93},[94,95],-118.18923,33.76696,{"lat":95,"lon":94},[98],{"name":99,"role":34,"phone":23,"phoneExt":23,"email":100},"Morgan R Timothy, MD","morgan.timothy@va.gov",{"facility":102,"status":40,"city":103,"state":90,"zip":104,"country":44,"countryCode":45,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"VA Palo Alto Health Care System, Palo Alto, CA","Palo Alto","94304-1207",{"type":47,"coordinates":106},[107,108],-122.14302,37.44188,{"lat":108,"lon":107},[111],{"name":112,"role":34,"phone":113,"phoneExt":23,"email":114},"Cheung Ramsey, MD","650-493-5000","ramsey.cheung@va.gov",{"facility":116,"status":40,"city":117,"state":90,"zip":118,"country":44,"countryCode":45,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"VA Northern California Health Care System, Mather, CA","Sacramento","95655-4200",{"type":47,"coordinates":120},[121,122],-121.4944,38.58157,{"lat":122,"lon":121},[125],{"name":126,"role":34,"phone":23,"phoneExt":23,"email":127},"Anthony Albanese, MD","anthony.albanese@va.gov",{"facility":129,"status":40,"city":130,"state":90,"zip":131,"country":44,"countryCode":45,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"VA San Diego Healthcare System, San Diego, CA","San Diego","92161-0002",{"type":47,"coordinates":133},[134,135],-117.16472,32.71571,{"lat":135,"lon":134},[138],{"name":139,"role":34,"phone":140,"phoneExt":23,"email":23},"Heather Patton, MD","858-260-0190",{"facility":142,"status":40,"city":143,"state":90,"zip":144,"country":44,"countryCode":45,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"VA Greater Los Angeles Healthcare System, West Los Angeles, CA","West Los Angeles","90073-1003",{"type":47,"coordinates":146},[147,148],-118.43068,34.0462,{"lat":148,"lon":147},[151],{"name":152,"role":34,"phone":23,"phoneExt":23,"email":153},"Joseph Pisegna, MD","joseph.pisegna@va.gov",{"facility":155,"status":40,"city":156,"state":157,"zip":158,"country":44,"countryCode":45,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Rocky Mountain Regional VA Medical Center, Aurora, CO","Aurora","Colorado","80045-7211",{"type":47,"coordinates":160},[161,162],-104.83192,39.72943,{"lat":162,"lon":161},[165],{"name":166,"role":34,"phone":167,"phoneExt":23,"email":168},"Ashley M Lane, MD","720-723-6773","ashley.lane6@va.gov",{"facility":170,"status":40,"city":171,"state":172,"zip":173,"country":44,"countryCode":45,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"VA Connecticut Healthcare System West Haven Campus, West Haven, CT","West Haven","Connecticut","06516-2770",{"type":47,"coordinates":175},[176,177],-72.94705,41.27065,{"lat":177,"lon":176},[180],{"name":181,"role":34,"phone":23,"phoneExt":23,"email":182},"Sofia Jakab, MD","sofia.jakab@va.gov",{"facility":184,"status":40,"city":185,"state":186,"zip":187,"country":44,"countryCode":45,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Washington DC VA Medical Center, Washington, DC","Washington D.C.","District of Columbia","20422-0001",{"type":47,"coordinates":189},[190,191],-77.03637,38.89511,{"lat":191,"lon":190},[194],{"name":195,"role":34,"phone":196,"phoneExt":23,"email":197},"Atoosa Rabiee, MD","202-745-8000","Atoosa.Rabiee@va.gov",{"facility":199,"status":40,"city":200,"state":201,"zip":202,"country":44,"countryCode":45,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Miami VA Healthcare System, Miami, FL","Miami","Florida","33125",{"type":47,"coordinates":204},[205,206],-80.19366,25.77427,{"lat":206,"lon":205},[209],{"name":210,"role":34,"phone":211,"phoneExt":212,"email":213},"Binu John, MD","305-575-7000","176","Binu.John@va.gov",{"facility":215,"status":216,"city":217,"state":201,"zip":218,"country":44,"countryCode":45,"cosmosGeoPoint":219,"geoPoint":223,"contacts":23},"James A. Haley Veterans' Hospital, Tampa, FL","ACTIVE_NOT_RECRUITING","Tampa","33612",{"type":47,"coordinates":220},[221,222],-82.45843,27.94752,{"lat":222,"lon":221},{"facility":225,"status":40,"city":226,"state":227,"zip":228,"country":44,"countryCode":45,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Atlanta VA Medical and Rehab Center, Decatur, GA","Decatur","Georgia","30033-4004",{"type":47,"coordinates":230},[231,232],-84.29631,33.77483,{"lat":232,"lon":231},[235],{"name":236,"role":34,"phone":237,"phoneExt":238,"email":239},"Thuy-Van Hang, MD","404-321-6111","x2067","Thuy-Van.Hang@va.gov",{"facility":241,"status":40,"city":242,"state":243,"zip":244,"country":44,"countryCode":45,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Robley Rex VA Medical Center, Louisville, KY","Louisville","Kentucky","40206-1433",{"type":47,"coordinates":246},[247,248],-85.75941,38.25424,{"lat":248,"lon":247},[251],{"name":252,"role":34,"phone":253,"phoneExt":23,"email":254},"Ashutosh Barve, MD","502-287-4000","ashutosh.barve@va.gov",{"facility":256,"status":40,"city":257,"state":258,"zip":259,"country":44,"countryCode":45,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD","Baltimore","Maryland","21201",{"type":47,"coordinates":261},[262,263],-76.61219,39.29038,{"lat":263,"lon":262},[266],{"name":267,"role":34,"phone":268,"phoneExt":23,"email":269},"Zurabi Lominadze, MD","502-541-7093","Zurabi.Lominadze@va.gov",{"facility":271,"status":40,"city":272,"state":273,"zip":274,"country":44,"countryCode":45,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","Boston","Massachusetts","02130-4817",{"type":47,"coordinates":276},[277,278],-71.05977,42.35843,{"lat":278,"lon":277},[281],{"name":282,"role":34,"phone":23,"phoneExt":23,"email":283},"Gyorgy Baffy, MD","gyorgy.baffy@va.gov",{"facility":285,"status":40,"city":286,"state":287,"zip":288,"country":44,"countryCode":45,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"VA Ann Arbor Healthcare System, Ann Arbor, MI","Ann Arbor","Michigan","48105-2303",{"type":47,"coordinates":290},[291,292],-83.74088,42.27756,{"lat":292,"lon":291},[295],{"name":296,"role":34,"phone":23,"phoneExt":23,"email":297},"Grace L Su, MD","grace.su@va.gov",{"facility":299,"status":40,"city":300,"state":301,"zip":302,"country":44,"countryCode":45,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"St. Louis VA Medical Center John Cochran Division, St. Louis, MO","St Louis","Missouri","63106-1621",{"type":47,"coordinates":304},[305,306],-90.19789,38.62727,{"lat":306,"lon":305},[309],{"name":310,"role":34,"phone":311,"phoneExt":312,"email":23},"Melissa Kaltenbach, MD","314-652-4100","57030",{"facility":314,"status":40,"city":315,"state":316,"zip":317,"country":44,"countryCode":45,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE","Omaha","Nebraska","68105-1850",{"type":47,"coordinates":319},[320,321],-95.94043,41.25626,{"lat":321,"lon":320},[324],{"name":325,"role":34,"phone":23,"phoneExt":23,"email":326},"Peter Mannon, MD","peter.mannon@va.gov",{"facility":328,"status":40,"city":329,"state":329,"zip":330,"country":44,"countryCode":45,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"VA NY Harbor Healthcare System, New York, NY","New York","10010-5011",{"type":47,"coordinates":332},[333,334],-74.00597,40.71427,{"lat":334,"lon":333},[337],{"name":338,"role":34,"phone":339,"phoneExt":340,"email":341},"Daniel Dileo, MD","718-836-6600","6939","Daniel.Dileo@va.gov",{"facility":343,"status":40,"city":344,"state":329,"zip":345,"country":44,"countryCode":45,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"James J. Peters VA Medical Center, Bronx, NY","The Bronx","10468-3904",{"type":47,"coordinates":347},[348,349],-73.86641,40.84985,{"lat":349,"lon":348},[352],{"name":353,"role":34,"phone":354,"phoneExt":355,"email":356},"Tae H Lee, MD","718-584-9000","3600","tae.lee@va.gov",{"facility":358,"status":40,"city":359,"state":360,"zip":361,"country":44,"countryCode":45,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875",{"type":47,"coordinates":363},[364,365],-78.89862,35.99403,{"lat":365,"lon":364},[368],{"name":369,"role":34,"phone":370,"phoneExt":23,"email":371},"Cynthia Moylan, MD","919-286-0411","Cynthia.Moylan@va.gov",{"facility":373,"status":40,"city":374,"state":360,"zip":375,"country":44,"countryCode":45,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC","Salisbury","28144",{"type":47,"coordinates":377},[378,379],-80.47423,35.67097,{"lat":379,"lon":378},[382],{"name":383,"role":34,"phone":384,"phoneExt":385,"email":386},"Leon Kundrotas, MD","704-638-9000","32580","leon.kundrotas@va.gov",{"facility":388,"status":40,"city":389,"state":390,"zip":391,"country":44,"countryCode":45,"cosmosGeoPoint":392,"geoPoint":396,"contacts":397},"Louis Stokes VA Medical Center, Cleveland, OH","Cleveland","Ohio","44106-1702",{"type":47,"coordinates":393},[394,395],-81.69541,41.4995,{"lat":395,"lon":394},[398],{"name":399,"role":34,"phone":23,"phoneExt":23,"email":400},"Percia Davitkav, MD","percia.davitkov@va.gov",{"facility":402,"status":40,"city":403,"state":404,"zip":405,"country":44,"countryCode":45,"cosmosGeoPoint":406,"geoPoint":410,"contacts":411},"VA Portland Health Care System, Portland, OR","Portland","Oregon","97207-2964",{"type":47,"coordinates":407},[408,409],-122.67621,45.52345,{"lat":409,"lon":408},[412],{"name":413,"role":34,"phone":414,"phoneExt":415,"email":416},"Janice Jou, MD","503-220-8262","58126","Janice.Jou@va.gov",{"facility":418,"status":40,"city":419,"state":420,"zip":421,"country":44,"countryCode":45,"cosmosGeoPoint":422,"geoPoint":426,"contacts":427},"Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA","Philadelphia","Pennsylvania","19104-4551",{"type":47,"coordinates":423},[424,425],-75.16362,39.95238,{"lat":425,"lon":424},[428],{"name":429,"role":34,"phone":23,"phoneExt":23,"email":430},"David Kaplan, MD","david.kaplan@va.gov",{"facility":432,"status":40,"city":433,"state":434,"zip":435,"country":44,"countryCode":45,"cosmosGeoPoint":436,"geoPoint":440,"contacts":441},"Ralph H. Johnson VA Medical Center, Charleston, SC","Charleston","South Carolina","29401-5703",{"type":47,"coordinates":437},[438,439],-79.93275,32.77632,{"lat":439,"lon":438},[442],{"name":443,"role":34,"phone":444,"phoneExt":23,"email":445},"Don Rockey, MD","843-577-5011","Don.Rockey@va.gov",{"facility":447,"status":40,"city":448,"state":434,"zip":449,"country":44,"countryCode":45,"cosmosGeoPoint":450,"geoPoint":454,"contacts":455},"Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC","Columbia","29209-1638",{"type":47,"coordinates":451},[452,453],-81.03481,34.00071,{"lat":453,"lon":452},[456],{"name":457,"role":34,"phone":23,"phoneExt":23,"email":458},"Nicholas Hoppmann, MD","Nicholas.Hoppmann2@va.gov",{"facility":460,"status":40,"city":461,"state":462,"zip":463,"country":44,"countryCode":45,"cosmosGeoPoint":464,"geoPoint":468,"contacts":469},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":47,"coordinates":465},[466,467],-96.80667,32.78306,{"lat":467,"lon":466},[470],{"name":471,"role":34,"phone":472,"phoneExt":23,"email":473},"Jacqueline Oleary, MD","214-857-0403","Jacqueline.Oleary@va.gov",{"facility":475,"status":40,"city":476,"state":462,"zip":477,"country":44,"countryCode":45,"cosmosGeoPoint":478,"geoPoint":482,"contacts":483},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","77030-4211",{"type":47,"coordinates":479},[480,481],-95.36327,29.76328,{"lat":481,"lon":480},[484],{"name":485,"role":34,"phone":23,"phoneExt":23,"email":486},"Ruben Hernaez, MD","ruben.hernaez@va.gov",{"facility":488,"status":40,"city":489,"state":490,"zip":491,"country":44,"countryCode":45,"cosmosGeoPoint":492,"geoPoint":496,"contacts":497},"VA Salt Lake City Health Care System, Salt Lake City, UT","Salt Lake City","Utah","84148-0001",{"type":47,"coordinates":493},[494,495],-111.89105,40.76078,{"lat":495,"lon":494},[498],{"name":499,"role":34,"phone":500,"phoneExt":501,"email":502},"Tuan Pham, MD","801-582-1565","1234","Tuan.Pham@va.gov",{"facility":29,"status":40,"city":504,"state":505,"zip":506,"country":44,"countryCode":45,"cosmosGeoPoint":507,"geoPoint":511,"contacts":512},"Seattle","Washington","98108-1532",{"type":47,"coordinates":508},[509,510],-122.33207,47.60621,{"lat":510,"lon":509},[513,515],{"name":33,"role":34,"phone":514,"phoneExt":23,"email":36},"206-277-3136",{"name":28,"role":30,"phone":23,"phoneExt":23,"email":23},{"facility":517,"status":40,"city":518,"state":519,"zip":520,"country":44,"countryCode":45,"cosmosGeoPoint":521,"geoPoint":525,"contacts":526},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",{"type":47,"coordinates":522},[523,524],-89.40123,43.07305,{"lat":524,"lon":523},[527],{"name":528,"role":34,"phone":23,"phoneExt":23,"email":529},"Adnan Said, MD","adam.said@va.gov",{"type":531,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100476640","preventing-liver-cancer-mortality-through-imaging-with-ultrasound-vs-mri-100476640",false,"NCT05486572","Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI","CSP #2023 - Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI (The PREMIUM Study)","PREMIUM","Inclusion Criteria:\n\n1. Cirrhosis due to any underlying etiology diagnosed by one or more of the following:\n\n   * Histology of liver biopsy\n   * Radiologic criteria (nodular liver, evidence of portal hypertension)\n   * Clinical signs of cirrhosis (gastroesophageal varices, ascites, hepatic encephalopathy)\n   * Vibration controlled transient elastography (VCTE, specifically Fibroscan, which is available in all participating sites) with liver stiffness \\>12.5kPa or magnetic resonance elastography \\>5.0 kPa\n2. High Risk of Liver Cancer: This will be defined by one or more of the following:\n\n   * Current HCV infection (detectable HCV RNA)\n   * FIB-4 score 3.25, within 6 months of randomization\n   * Estimated annual HCC incidence \\>2.5%, within 6 months of randomization, calculated by VA-specific models that the investigators developed (available on the national VA ALD Dashboard and at www.hccrisk.com).\n3. Age 18-75\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Prior diagnosis or of HCC\n2. Current suspicion of HCC\n3. Prior receipt of organ transplantation\n4. Currently listed for organ transplantation.\n5. Participation in a conflicting HCC screening trial\n6. Advanced liver dysfunction, defined by Child C Cirrhosis (CTP score 10), or MELD score \\>20, within 6 months prior to randomization\n7. Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\n8. Multiple comorbid conditions resulting in limited life expectancy, defined by a cirrhosis-specific comorbidity index (CirCom)112 score 3. Of note, early stage malignancies of the bladder, lung, or prostate will not be excluded.\n9. Estimated life expectancy \\\u003C5 years as determined by the clinical judgement of the Study Investigator\n10. Contraindications to undergoing contrast-enhanced MRI:\n\n    * Allergy to gadolinium-based contrast agents\n    * MRI-incompatible implantable devices (e.g. pacemakers, defibrillators, resynchronization devices)\n    * Implantable neurostimulation device\n    * Implantable cochlear implant\u002Fear implant\n    * Drug infusion pumps (e.g. insulin pump, analgesic or chemotherapy pumps)\n    * Metallic foreign bodies in or around the eye\n    * Metallic fragments, such as bullets, shotgun pellets or shrapnel\n    * Metallic body piercings that cannot be removed\n    * Cerebral artery aneurysm clips\n    * Severe claustrophobia\n    * Unable to fit on MRI machine due to weight (weight \\>400lbs) or body habitus\n11. Inability to complete planned study visits (e.g. lives too far from VA, no transportation, etc.)\n12. Currently pregnant","ALL","18 Years","75 Years",{"count":544,"type":545},4700,"ESTIMATED","INTERVENTIONAL",[548],"NA","The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.",[551,552],"Carcinoma, Hepatocellular","Cirrhosis",[554,555,556,557,558,559],"hepatic, oncology","liver","chronic diseases; health services and systems","prospective, randomized, clinical trial","magnetic resonance imaging; ultrasonography","cirrhosis; liver cancer","2026-06-15",{"date":562,"type":563},"2026-06-17","ACTUAL",{"date":565,"type":563},"2023-11-03",{"date":567,"type":545},"2031-09-01",{"name":5,"class":6},34]