[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psc":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,44,68,92,115,127,152,182],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054113","petmri-of-primary-sclerosing-cholangitis-100054113",false,"NCT06252610","PET\u002FMRI of Primary Sclerosing Cholangitis","PET\u002FMRI Evaluation in Patients With Primary Sclerosing Cholangitis Using Intercellular Matrix Radiopharmaceuticals","Inclusion Criteria:\n\n* Established clinical diagnosis of large duct PSC\n* Participants receiving treatment for IBD are allowed if on a stable dose from screening and expected to remain stable for the duration of the study\n* Serum AST and ALT concentration ≤ 8 times the upper limit of normal\n\nExclusion Criteria:\n\n* Other causes of chronic liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically\n* Known or suspected overlapping clinical or histologic diagnosis of autoimmune hepatitis\n* Subjects less than 18 years of age or greater than 85 years of age.\n* Subjects with electrical implants, such as cardiac pacemakers or perfusion pumps.\n* Subjects with ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing.\n* Subjects who anticipate being pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate).\n* Subjects with claustrophobic reactions\n* Subjects with more significant than average potential for cardiac arrest.\n* Subjects with a history of major head trauma (i.e., multiple concussions, traumatic brain injury).\n* Subjects with a history of bleeding disorders.\n* Subjects whose research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months).\n* Subjects unable to lie comfortably on a bed inside the PET\u002FMRI bore as assessed by physical examination and medical history (e.g., back pain, arthritis).\n* Subjects under the direct supervision of the principal investigator;\n* Subjects with a body weight of \\> 300 lbs (operational weight limit of the PET\u002FMRI table) or BMI \\>33 kg\u002Fm2 (the Athinoula A. Martinos Center standard procedure to avoid claustrophobia or mechanical impossibility of fitting the subject into the scanner bore, which is less than 60 cm wide).\n* A history of acute or chronic severe renal insufficiency (glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2\n* Perioperative liver transplantation period.\n* A history of systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, or other comorbidities resulting in chronic kidney disease stage IV or higher","ALL","18 Years","99 Years",{"count":20,"type":21},10,"ESTIMATED","OBSERVATIONAL","This study aims to use positron emission tomography (PET)\u002Fmagnetic resonance imaging (MRI) to diagnose and quantify PSC-related biliary tract fibrosis and to improve upon the currently available non-invasive diagnostic capabilities by investigating the ability of combined PET\u002FMRI to detect and quantify fibrosis using a novel collagen-binding radiotracer. Specifically, the investigators will be comparing \\[68Ga\\]CBP8- and \\[18F\\]-FAPI-74 PET\u002FMRI to a liver transient elastography scan in the diagnosis of biliary tree fibrosis.",[25],"PSC",[25,27,28,29,30],"[18F]-FAPI-74","[68Ga]CBP8-PET","PET\u002FMR","Fibrosis","NOT_YET_RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-08-10",{"date":39,"type":21},"2029-04-30",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100538988","global-prospective-observational-cohort-of-adult-patients-with-primary-sclerosing-cholangitis-wind-psc-study-100538988","NCT06297993","Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)","A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC)","WIND-PSC","Inclusion Criteria:\n\n1. Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF).\n2. Confirmed clinical diagnosis of large duct PSC.\n\nExclusion Criteria:\n\n1. Clinically significant acute or chronic liver disease of an etiology other than PSC (including but not limited to metabolic-dysfunction associated steatohepatitis (MASH), PBC, HCV, HBV, or alcoholic hepatitis, Wilson's disease, alpha-1 antitryp-sin deficiency, acute or chronic drug-induced liver injury)\n\n   * Patients with PSC and elements of AIH overlap are allowed to enroll\n   * Patients with metabolic dysfunction associated steatotic liver disease (MASLD) or benign steatosis are allowed to enroll\n2. Small-Duct PSC.\n3. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.\n4. Clinically diagnosed infections (including acute cholangitis) and receiving treatment within the past 7 days; patients on chronic suppressive antibiotics for acute cholangitis will be allowed to enroll\n5. Hospitalization in the past 7 days\n6. UDCA dose \\>28 mg\u002Fkg\n7. Evidence of current or historical decompensated cirrhosis based on the following clinical events:\n\n   * Ascites \\> Grade 2 and requiring treatment\n   * Esophageal or gastric variceal bleeding requiring hospitalization\n   * Hepatic encephalopathy (as defined by a West Haven score ≥ 2)\n   * Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \\>250\u002Fmm3 in the absence of an intra-abdominal source of infection\n   * AKI-HRS according to AASLD Guidelines (Flamm 2021)\n   * Portal hypertension based on a platelet count \\\u003C 150 × 109\u002FL and LSM \\> 15 kPa with clinical, laboratory, imaging and\u002For other relevant parameters\n8. Prior liver transplantation\n9. MELD 3.0 Score \\>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.\n10. History, evidence, or high suspicion of hepatobiliary malignancies or active colon cancer based on imaging, screening laboratory values, and\u002For clinical symptoms. Patients with a history of colon cancer who have undergone a colectomy and have no current evidence of colon cancer will be allowed to enroll in the study.\n11. Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 52 weeks.\n12. Participants who are impaired, incapacitated, or incapable of completing study-related assessments or giving informed consent.\n13. Prisoners or participants who are involuntarily incarcerated.\n14. Participants who are currently participating in an investigational PSC therapy clinical study or who have participated in such a study within the past 12 weeks\n15. Absence of data in medical records to assess inclusion and exclusion criteria.","75 Years",{"count":54,"type":21},2000,"Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.",[25],"RECRUITING","2026-06-24",{"date":60,"type":35},"2026-06-29",{"date":62,"type":35},"2024-05-06",{"date":64,"type":21},"2031-01",{"name":66,"class":42},"PSC Partners Seeking a Cure",18,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100582639","colangioids-to-define-the-genetic-factors-involved-in-atypical-primary-sclerosing-cholangitis-100582639","NCT06865924","Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis","CILIA","Inclusion Criteria:\n\n* Between 18 and 90 years of age\n* Of both sexes\n* willingness to sign informed consent for the study; Additional criteria group 1\n* Patients with a confirmed aPSC diagnosis Additional criteria group 2\n* patients with suspected PSC liver biopsy candidates Additional criteria group 3\n* Patients not affected by aPSC listed for the following procedures:\n* Liver resection for hepatocellular or other hepatic lesions (including secondary effects from other cancers and benign focal lesions, which will result in healthy liver tissue);\n* Post-transplant biopsies of healthy liver;\n* cholecystectomies. Additional criteria group 4\n* Patients previously genotyped in the study \"Impact of complete exoma sequencing on clinical management of patient with non-alcoholic liver steatosis and cryptogenic liver disease project code RF-2016-02364358\" results carrying gene variants associated with ciliopathies\n\nExclusion Criteria:\n\n-Positive for chronic viral hepatitis (HCV-RNA and HBsAg).","90 Years",{"count":77,"type":21},80,"INTERVENTIONAL",[80],"NA","Primary sclerosing cholangitis (PSC) is a rare, progressive and often fatal disease of the intrahepatic or extrahepatic bile ducts, with an estimated prevalence in Western countries of 1\u002F10,000. Biliary disease in PSC is represented by cholestasis, chronic inflammation of the bile ducts, the small tubes through which bile passes, progressive concentric fibrosis around the bile ducts2. This results in an obstruction to the passage of bile, which can lead to the development of cirrhosis with complications related to portal hypertension, cholangitis and often progress to bile duct cancer (cholangiocarcinoma). The only curative therapy in patients with PSC is liver transplantation, since no drug has been shown to be effective in preventing disease progression. The etiology is most likely multifactorial immune-mediated, where the onset of PSC is triggered by environmental factors in a genetically susceptible host2Genome-wide association studies (GWAS) have identified variations at the human leukocyte antigen (HLA) complex on chromosome 6 and several other loci, but these explain only a small part of the heritability of PSC. In most cases, PSC occurs in men in their 30s and 40s who have inflammatory bowel disease (IBD) suggesting a key role of altered intestinal permeability and inflammation. However, approximately 30% of patients do not present colonic inflammation, which is consistent with the heterogeneity of the disease. Preliminary data obtained in our laboratory analyzing a cohort of Italian individuals with atypical PSC (aPSC), identified a suggestive enrichment of rare variants in genes involved in cilia morphogenesis (CEP120 and AHI1). These data are consistent with previous findings, showing the correlation between gene variants involved in ciliopathies, including the DCDC26 gene, and chronic cholestatic disorders that can mimic PSC. Primary cilia are organelles present on the outer membrane of ductal cells, called cholangiocytes. These organelles function as antennas that detect stimuli from bile and transmit information to cells by regulating various signaling pathways involved in secretion, proliferation and apoptosis. Therefore, the alteration of primary cilia plays an important role in the de-differentiation of cholangiocytes and therefore in the development of cholangiopathies, in the invasion of inflammatory cells and in the fibrotic process. However, to date little is known about the contribution of genetic variants to the severity and progression of PSC, perhaps also due to the lack of a reliable model of bile duct. Recently, three-dimensional cell cultures, called organoids, have been proposed as a revolutionary tool in the field of cell biology, as they are able to mimic the corresponding organ in vivo.Organoids can be derived from either induced pluripotent stem cells (iPSCs) or tissue-resident adult stem cells. Compared to conventional 2D cultures and animal models, organoids allow to reproduce the genetic background of the patient in the model, recapitulating in vitro structures and functions similar to in vivo tissues. For this reason, organoids have been exploited in different applications, including drug discovery and testing, precision medicine and cell therapy 9311. However, organoids still show several limitations to model liver diseases. Indeed, they are only able to recapitulate the hepatic epithelial component, cholangiocytes and\u002For hepatocytes and above all they lack the 3D hepatic microenvironment, such as stromal and immune cells, which play an important role in the pathogenesis of several liver diseases. The present study is part of a project funded by the Regional Foundation for Biomedical Research (FRRB) whose general objective is to generate three-dimensional models of primary sclerosing cholangitis (PSC), called assemblyloids, and to study the cellular and molecular mechanisms through which genetic variants associated with genes involved in ciliopathies accelerate the progression of PSC. Our hypothesis is that the loss of function of cilia in cholangiocytes may represent a link between cellular senescence, development of inflammation, fibrosis and finally liver cancer. The variants related to ciliopathies could lead to an incomplete maturation of cholangiocytes with consequent malfunction that can therefore lead to a chronic inflammation of ductal cells and therefore to a persistent and uncontrolled activation of stromal cells and infiltration of immune cells. Furthermore, the generation of assemblyloids capable of reproducing native tissue as faithfully as possible will provide a new in vitro model for testing new pharmacological approaches aimed at correcting genetic mutations for improved precision medicine.",[25],"2026-03-23",{"date":85,"type":35},"2026-03-24",{"date":87,"type":35},"2024-12-01",{"date":89,"type":21},"2027-12-31",{"name":91,"class":42},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":16,"minAge":17,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":43},"100420380","characterization-of-biliary-cell-derived-organoids-from-bile-of-psc-and-non-psc-patients-100420380","NCT04753996","Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients","Inclusion Criteria:\n\nPSC\n\n* Patients diagnosed with PSC between the age of 18 and 85.\n* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings and compatible liver biopsies if available.\n* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. Patients with PSC and Cholangiocarcinoma will be included.\n\nControls\n\n• Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85.\n\nExclusion Criteria:\n\n* Patients unable to provide inform consent.\n* Prisoners and institutionalized individuals.\n* PSC with orthotopic liver transplantation\n* History of Roux En Y procedure",true,"85 Years",{"count":101,"type":21},300,"The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.",[104,25,105],"Primary Sclerosing Cholangitis","Cholangiocarcinoma","2026-02-12",{"date":108,"type":35},"2026-02-17",{"date":110,"type":35},"2021-03-08",{"date":112,"type":21},"2035-01-01",{"name":114,"class":42},"Mayo Clinic",{"id":116,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":118,"keywords":119,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":126,"locationsCount":43},"100535498",{"count":20,"type":21},[25],[25,27,28,29,30],"2025-10-15",{"date":122,"type":35},"2025-10-16",{"date":124,"type":21},"2026-05-10",{"date":39,"type":21},{"name":41,"class":42},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":22,"phases":4,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100297049","swiss-primary-sclerosing-cholangitis-cohort-study-100297049","NCT03146936","Swiss Primary Sclerosing Cholangitis Cohort Study","Inclusion Criteria:\n\n* Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases) of any age. Patients not fulfilling such criteria but still diagnosed with PSC in a hepatology referral centre can be included\n* patients living in Switzerland\n\nExclusion Criteria:\n\n* N\u002FA",{"count":134,"type":21},120,"5 Years","Research project in which biological material is sampled and health-related personal data is further used and collected.\n\nCoded data are used.",[138,25,139],"Cholangitis, Sclerosing","Primary Sclerosing Cholangitis (PSC)",[25,104,141],"Cohort","2025-08-14",{"date":144,"type":35},"2025-08-19",{"date":146,"type":35},"2017-02-28",{"date":148,"type":21},"2030-12-31",{"name":150,"class":42},"Fondazione Epatocentro Ticino",21,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":159,"targetDuration":4,"studyType":78,"phases":160,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100585645","phase-2-pharmacologic-approaches-to-preventing-primary-sclerosing-cholangitis-recurrence-after-liver-transplantation-100585645","NCT06905054","Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Inclusion criteria:\n\n* Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment\n* Absence of rPSC at time of study enrollment\n* At least one of the following additional features that increase risk of rPSC\n\n  * LT performed for cholangiocarcinoma\n  * Concurrent inflammatory bowel disease\n  * Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment\n  * Any episode of acute cellular rejection in the post-transplant period before the study enrollment\n* If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion\u002Fexclusion criteria.\n* Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and\u002For are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.\n\nExclusion criteria:\n\n* Presence of ischemic cholangiopathy which can mimic rPSC\n* LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis\n* Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC\n* History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC\n* Baseline GFR \\\u003C30 ml\u002Fmin which precludes administration of fenofibrate\n* Previously known intolerance or allergy to fenofibrate\n* Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment\n* Female participants that are pregnant or planning to become pregnant",{"count":77,"type":21},[161],"PHASE2","This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with",[104,164,25,165],"Liver Transplant, Complications","Biliary Strictures",[167,168,169,170,171,172,173],"primary sclerosing cholangitis","recurrent primary sclerosing cholangitis","liver transplant complication","fenofibrate","fibrate","PPAR agonist","peroxisome proliferated activated receptor agonist","2025-06-25",{"date":176,"type":35},"2025-06-27",{"date":178,"type":35},"2025-04-15",{"date":180,"type":21},"2028-07-01",{"name":114,"class":42},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":98,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":189,"targetDuration":4,"studyType":78,"phases":191,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":214},"100559302","early-phase-1-a-microdose-trial-investigating-binding-of-68gaga-dota-cys-ath001-in-healthy-subjects-and-different-patient-groups-100559302","NCT06562361","A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.","A First-In-Human, Microdosing, Clinical Trial to Investigate Binding of the PET Tracer [68Ga]Ga-DOTA-CYS-ATH001 Targeting PDGFRβ in Healthy Subjects as Compared to Patients With MASH, PSC and CD","Inclusion Criteria:\n\n1. Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.\n2. Male or female participant aged 18 to 75 years, inclusive, at the screening visit.\n3. Body mass index (BMI) ≥ 19 and \\\u003C 40.0 kg\u002Fm2 at the time of the screening visit.\n4. Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective method of contraception with a failure rate of \\\u003C 1 % to prevent pregnancy from at least 2 weeks prior to administration of tracer for at least 1 week after the PET imaging examination (or for at least 1 weak after the last PET imaging examination for those participants undergoing test\u002Fretest PET imaging). In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom during the same time period.\n\n   The following are considered highly effective methods of contraception:\n   * combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),\n   * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),\n   * intra-uterine device \\[IUD\\]or intra-uterine hormone-releasing system \\[IUS\\]) WOCBP must refrain from donating eggs until 3 months after the last tracer administration.\n\n   WOCBP with an exclusive male partner who has undergone vasectomy may choose not to use contraceptives.\n\n   Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle-stimulating hormone \\[FSH\\] \\>25 IU\u002FL is confirmatory).\n\n   Male participants must be willing to use condom or be vasectomized or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of tracer until 3 months after the administration of tracer. Any female partner of a non-vasectomized male participant who is of childbearing potential must use contraceptive methods with a failure rate of \\\u003C 1% to prevent pregnancy (see above) from at least 2 weeks prior to administration of tracer to 4 weeks after administration of tracer.\n\n   Cohort-specific inclusion criteria:\n\n   Cohort 1 (healthy participants)\n5. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.\n\n   Cohort 2 (presumed MASH patients) MASH diagnosis based on non-invasive assessments. Participants should have a high level of disease activity with regards to pro-peptide of type III collagen (ProC3) as a marker of ongoing fibrogenesis.\n6. Steatosis according to biopsy, radiology, or controlled attenuation parameter (CAP) (≥ 280 dB\u002FM 8), assessments ≤ 24 weeks prior to the screening visit.\n7. At least 1 cardiometabolic criteria from the following list:\n\n   A. BMI ≥ 25 kg\u002Fm2 \\[23 Asia\\] OR waist circumference (WC) \\> 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol\u002FL \\[100 mg\u002FdL\\] OR 2-hour post-load glucose levels ≥ 7.8 mmol\u002FL \\[≥ 140 mg\u002FdL\\] OR HbA1c ≥ 5.7% \\[39 mmol\u002FL) OR type 2 diabetes OR treatment for type 2 diabetes, C. Blood pressure ≥ 130\u002F85 mmHg OR specific antihypertensive drug treatment, D. Plasma triglycerides ≥ 1.70 mmol\u002FL \\[150 mg\u002FdL\\] OR lipid-lowering treatment, E. Plasma high-density lipoprotein (HDL)-cholesterol ≤ 1.0 mmol\u002FL \\[40 mg\u002FdL\\] (M) and ≤ 1.3 mmol\u002FL \\[50 mg\u002FdL\\] (F) OR lipid-lowering treatment.\n8. ProC3 ≥ 12.6 ng\u002FmL. Cohort 3 (verified MASH patients) MASH diagnosis based on historical liver biopsy. Participants should have a high level of disease activity with regards to ProC3 as a marker of ongoing fibrogenesis, to allow for correlation to PET-tracer uptake.\n9. Evidence of steatosis according to biopsy, radiology, or CAP (≥ 280 dB\u002FM) or MRI-PDFF, assessments ≤ 24 weeks prior to the screening visit.\n10. At least 1 cardiometabolic criteria from the following list:\n\n    A. BMI ≥ 25 kg\u002Fm2 \\[23 Asia\\] OR WC \\> 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol\u002FL \\[100 mg\u002FdL\\] OR 2-hour post-load glucose levels ≥ 7.8 mmol\u002FL \\[≥ 140 mg\u002FdL\\] OR HbA1c ≥ 5.7% \\[39 mmol\u002FL) OR type 2 diabetes OR treatment for type 2 diabetes, C. Blood pressure ≥ 130\u002F85 mmHg OR specific antihypertensive drug treatment, D. Plasma triglycerides ≥ 1.70 mmol\u002FL \\[150 mg\u002FdL\\] lipid-lowering treatment, E. Plasma HDL-cholesterol ≤ 1.0 mmol\u002FL \\[40 mg\u002FdL\\] (M) and ≤ 1.3 mmol\u002FL \\[50 mg\u002FdL\\] (F) OR lipid-lowering treatment.\n11. Historical liver biopsy 24 weeks to 4 weeks prior to inclusion with histologically proven metabolic dysfunction-associated steatotic liver disease (MASLD).\n12. ProC3 ≥ 12.6 ng\u002FmL. Cohort 4 (fibrostenotic CD patients)\n13. Fibrostenotic CD as evidenced by persistent luminal narrowing with or without obstructive symptoms as assessed with MRI, ≤ 24 weeks prior to the screening visit OR fibrostenotic CD by positive colonoscopy up to 24 weeks prior to the screening visit.\n14. Crohn's disease activity index (CDAI) \\\u003C 150\n15. Calprotectin \\\u003C 250\n16. C-reactive protein (CRP) \\\u003C 20 Cohort 5 (PSC patients)\n17. Large duct PSC, including intrahepatic bile duct involvement, according to MRI\u002FMRCP.\n18. ProC3 ≥ 12.6 ng\u002FmL\n\nExclusion Criteria:\n\n1. Any contraindication for MRI according to a standard checklist used in clinical practice, including claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, cardiac pacemaker, defibrillator, artificial valves in heart, aneurysm clips or coils, etc.), inability to stay in supine position for 90 minutes, and permanent makeup or tattoos which in the Investigator's opinion might jeopardize the participant's safety or interfere with the imaging assessments.\n2. Having worked as a metal worker or welder.\n3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.\n4. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the screening visit.\n5. Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or in situ prostate cancer under active surveillance, with no interventions scheduled during the period of trial participation.\n6. Any planned major surgery within the duration of the trial participation.\n7. Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.\n8. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B or C antibodies and\u002For human immunodeficiency virus (HIV).\n9. Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc.).\n10. Poor peripheral venous access, as judged by the Investigator.\n11. After 10 minutes of supine rest at the screening visit, any vital signs values outside the following ranges:\n\n    * Systolic blood pressure: \\\u003C 90 or \\>165 mmHg, or\n    * Diastolic blood pressure \\\u003C 50 or \\>100 mmHg, or\n    * Pulse \\\u003C 40 or \\> 90 bpm\n12. The participant has a change in body weight ≥5%, 3 months before the screening visit.\n13. The participant has any laboratory abnormality or condition that, in the Investigator's opinion, could adversely affect the safety of the participant or impair the assessment of trial results.\n14. Clinically significantly abnormal 12-lead ECG recording result or cardiac symptoms as judged by the Investigator.\n15. The participant is using any prohibited concomitant medications as described in the protocol, at the discretion of the Investigator.\n16. Current use of any hormone therapy at doses that may cause metabolic interference as judged by the Investigator. Stable hormonal replacement therapy is allowed.\n17. Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit or previous participation in another PET imaging trial within the last 12 months.\n18. Positive screening result for alcohol at the screening visit (cohorts 1a and 1b only).\n19. Ongoing or previous alcohol abuse, or long-standing excessive intake of alcohol, as judged by the Investigator.\n20. Presence or history of drug abuse, as judged by the Investigator.\n21. History of, or current use of anabolic steroids, as judged by the Investigator.\n22. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.\n23. The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.\n\n    Additional exclusion criteria for all participants (cohorts 2-5):\n24. The participant is receiving treatment with vitamin E, thiazolidinediones, or glucagon-like peptide-1 receptor agonists unless on a stable dose for 3 months before the screening Visit and is anticipated to maintain the same dosing regimen throughout trial participation.\n25. Participants with HbA1c ≥48 mmol\u002Fmol (6.5%) at screening without a previous diagnosis of T2D must not take part in the study. Participants with a previous diagnosis of T2D are permitted to enter the study if on a stable regimen of antidiabetic therapy for at least 3 months before screening. Participants who are on a stable regimen of antidiabetic therapy for at least 3 months before screening and have HbA1c of ≥ 63 mmol\u002Fmol (9%) at screening should be excluded.\n26. Clinically significant disease, apart from T2D, which in the opinion of the Investigator might interfere with the interpretation of the trial results and\u002For the safety of the participant, or in any other way unsuitable for participation in this clinical trial.\n27. The participant has a severe immune-mediated inflammatory disease (IMID) (e.g., rheumatoid arthritis, spondylarthritis disease spectrum, connective tissue disorders, cutaneous inflammatory conditions such as psoriasis, atopic dermatitis, hidradenitis suppurativa, asthma, multiple sclerosis). Participants with inactive IMID or active IMID of mild to moderate severity are permitted to enter the trial.\n\n    Additional exclusion criteria for MASH and PSC participants (cohorts 2-3, and 5)\n28. Liver stiffness \\> 25 kPa by transient elastography or any sign of decompensation. For cohorts 2 and 3, based on the FibroScan® evaluation on the screening visit, and for cohort 5 based on routine elastography performed ≤ 12 months.\n29. For participants with biopsy-confirmed fibrosis stage F2 or F3, the participant has any of the following during the screening period:\n\n    * Aspartate aminotransferase (AST) levels \\> 5 x the upper limit of normal (ULN).\n    * Alanine aminotransferase (ALT) levels \\> 5 x ULN.\n    * Alkaline phosphatase (ALP) ≥ 2 x ULN (cohorts 2 and 3) and ALP ≥ 10 (cohort 5).\n    * Serum creatinine ≥1.5 x ULN or has an estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73m2 (the revised Lund-Malmö GFR estimating equation will be used).\n    * International normalized ratio (INR) \\>1.3.\n    * Total TBL ≥ULN (except for patients with a documented history of Gilbert's syndrome if direct bilirubin is within the normal reference range).\n    * Direct bilirubin ≥ 3 x ULN.\n    * Platelet count \\\u003C 60 x 109\u002FL.\n    * Presence or history of ascites, hepatic encephalopathy, or variceal bleeding.\n    * Presence or history of Child-Pugh \\> 6 (Class B or C), unless due to therapeutic anticoagulation.\n    * Presence or history of Model for End-Stage Liver disease (MELD) score \\>12 (only for cohorts 2-3).\n\n    Note: It is the Investigator's decision, in consultation with the Sponsor, to allow participants to enter the study who have clinically meaningful rising tendencies in liver chemistries or significantly elevated liver chemistries that do not yet satisfy but could be interpreted as clinically concerning (i.e., AST or ALT \\> 4 x ULN) at any visit during the screening period.\n30. The participant has a change in body weight ≥ 5% after qualifying liver biopsy. Additional criteria for fibrostenotic CD participants (cohort 4)\n31. MRI findings consistent with only inflammation, i.e., edema, hyperemic intestinal wall, restricted diffusion, mesenteric lymphadenopathy etc.",{"count":190,"type":21},30,[192],"EARLY_PHASE1","The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer \\[68Ga\\]Ga-DOTA-Cys-ATH001 in the liver and\u002For gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC).The study will also assess the safety of a microdose of 68Ga\\]Ga-DOTA-Cys-ATH001 and how it is distributed in different parts of the body. The main questions the study aims to answer are:\n\n* What does the uptake of the \\[68Ga\\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the liver of healthy subjects, and in that of patients with MASH and PSC?\n* What does the uptake of the \\[68Ga\\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects, and that of patients with fibrostenotic CD?\n* How much \\[68Ga\\]Ga-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection?\n* How is \\[68Ga\\]Ga-DOTA-Cys-ATH001 uptake distributed in the body?\n* What medical problems do participants have when receiving \\[68Ga\\]Ga-DOTA-Cys-ATH001?\n\nParticipants will:\n\nReceive one administration of \\[68Ga\\]Ga-DOTA-Cys-ATH001, after which examination with PET is performed. Magnetic Resonance Imaging (MRI) is also used in the study to create a detailed picture of the body and its function which will facilitate the interpretation of the results of the PET examination. A subset of participants will have blood samples collected after the tracer administration to assess the blood levels of the tracer over time.\n\nA subset of participants will come back for a second visit where they will receive a second administration of \\[68Ga\\]Ga-DOTA-Cys-ATH001, followed by PET and MRI.\n\nA health check-up is performed before dosing, and a safety assessment will be performed after dosing. A remote follow-up visit is performed the day after the dosing visit.",[195,25,196,197],"MASH","Fibrostenotic Crohn's Disease","Healthy Volunteers",[199,200,201,195,25,202,203],"PET","Tracer","PDGFRB","MRI","Crohn´s Disease","2024-08-28",{"date":206,"type":35},"2024-08-29",{"date":208,"type":21},"2024-08",{"date":210,"type":21},"2026-03",{"name":212,"class":213},"Antaros Medical","INDUSTRY",3]