[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617073":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":52,"locations":61,"responsibleParty":87,"collaborators":27,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":27,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":27,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Early therapeutic effects","EXPERIMENTAL","* Diagnosed acute lymphatic leukemia\n* Treatment day \\\u003C 50 according to therapy protocol \u002F no administration of CPM before first examination\n* From 3 years to \\\u003C 18 years",[13,14,15,16],"Diagnostic Test: Ultrasound Localization Microscopy (ULM)","Diagnostic Test: Blood sample","Diagnostic Test: Urinanalysis","Diagnostic Test: Renal sonography",{"label":18,"type":10,"description":19,"interventionNames":20},"Late therapeutic effects","* Diagnosed acute lymphatic leukemia\n* Completed oncological treatment\n* From 3 years to \\\u003C 18 years",[13,14,15,16],[22,28,31,35,38,42,45,49],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIAGNOSTIC_TEST","Ultrasound Localization Microscopy (ULM)","Single Examination: ULM of the kidney after application of a contrast medium (SonoVue®, intravenous).",[9],null,{"type":23,"name":24,"description":29,"armGroupLabels":30,"otherNames":27},"ULM of the kidney after application of a contrast medium (SonoVue®, intravenous) at two different time points:\n\nTimepoint 1: Before initiation of therapy, latest day 50 before 1st high-dose methotrexate or cyclophosphamide.\n\nTimepoint 2: After termination of intensive treatment (after 6-9 months).",[18],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"Blood sample","Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access.",[9],{"type":23,"name":32,"description":36,"armGroupLabels":37,"otherNames":27},"Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access at Timepoint 1 and 2.",[18],{"type":23,"name":39,"description":40,"armGroupLabels":41,"otherNames":27},"Urinanalysis","Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes.",[9],{"type":23,"name":39,"description":43,"armGroupLabels":44,"otherNames":27},"Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes at Timepoint 1 and Timepoint 2.",[18],{"type":23,"name":46,"description":47,"armGroupLabels":48,"otherNames":27},"Renal sonography","Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others.",[9],{"type":23,"name":46,"description":50,"armGroupLabels":51,"otherNames":27},"Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others at time point 1 and time point 2.",[18],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":27,"email":57},"Axel Karow, MD","CONTACT","+4991318533118","axel.karow@uk-erlangen.de",{"name":59,"role":55,"phone":56,"phoneExt":27,"email":60},"Alexander Dierl, MD","alexander.dierl@uk-erlangen.de",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Department of Pediatrics and Adolescent Medicine","RECRUITING","Erlangen","Baveria","91054","Germany","DE",{"type":71,"coordinates":72},"Point",[73,74],11.00783,49.59099,{"lat":74,"lon":73},[77,79,80,82,83,85],{"name":54,"role":55,"phone":78,"phoneExt":27,"email":57},"+49 9131 8533118",{"name":59,"role":55,"phone":56,"phoneExt":27,"email":60},{"name":54,"role":81,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"name":59,"role":81,"phone":27,"phoneExt":27,"email":27},{"name":84,"role":81,"phone":27,"phoneExt":27,"email":27},"Eva-Maria Wild, MD",{"name":86,"role":81,"phone":27,"phoneExt":27,"email":27},"Henriette Grieshaber Bouyer Mandelbaum, MD",{"type":88,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100617073","evaluation-of-acute-and-chronic-nephrotoxicity-in-acute-lymphatic-leukemia-patients-using-ultrasound-localization-microscopy-100617073",false,"NCT07313878","Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy","HEALED","Inclusion Criteria:\n\n* Diagnosed acute lymphatic leukemia\n* From 3 years to \\\u003C 18 years\n* completed oncological treatment or treatment day \\\u003C 50 according to therapy protocol and no administration of CPM before first examination.\n\nExclusion Criteria:\n\n* Known allergic disposition to SonoVue \u002F other contrast agents\n* Tattoo in the area of the examination field\n* Pregnancy\n* Breastfeeding mothers\n* Contraindication for the use of Sonovue\n* Critical condition\n* Known clinically evident renal impairment","ALL","3 Years","17 Years",{"count":100,"type":101},30,"ESTIMATED","INTERVENTIONAL",[104],"NA","With increasing survival rates in pediatric oncology, reports of long-term side effects persisting decades after treatment are also rising. Clinically evident nephropathies occur in about 5.5% of survivors more than five years after therapy. Chemotherapeutic agents such as ifosfamide, cisplatin, and carboplatin, as well as kidney-directed treatments like radiation, surgery, or stem cell transplantation, increase this risk. Acute kidney injury has also been described in association with cyclophosphamide and high-dose methotrexate, which are used in the treatment of acute lymphoblastic leukemia (ALL). Studies show a high prevalence of albuminuria (around 14.5% of childhood cancer survivors), an early marker of kidney damage, while standard parameters like creatinine often become abnormal only at later stages.\n\nLeukemia survivors suffer from vascular late effects caused by persistent endothelial damage triggered by cancer therapies such as anthracyclines, cyclophosphamide, and asparaginase, which increase inflammation and thrombosis risk. These vascular changes may also contribute to kidney injury.\n\nULM is a high-resolution ultrasound technique that uses microbubbles to visualize the microvasculature and resolve dynamic blood flow changes with a resolution beyond the diffraction limit. ULM is independent of kidney or liver function, has been applied in various organs, and was recently used for the first time to visualize glomeruli-the smallest functional units of the kidney-in humans. This method enables early detection of glomerular injury as a consequence of vascular damage, even before albuminuria appears, potentially allowing earlier adaptation of follow-up and initiation of treatment.\n\nThis pilot project focuses on survivors of ALL, as they are the largest and best studied pediatric cancer patient group also regarding late effects and, therefore, a sufficient number of individuals can be expected for his monocentric approach. Vascular functional impairment of the kidney could be detected at an early stage and the follow-up structures and measures such as the early use of nephroprotective drugs could be adapted.",[107,108],"Acute Lymphoblastic Leukaemias (ALL)","Long Term Follow-Up","2025-12-22",{"date":111,"type":112},"2026-01-02","ACTUAL",{"date":114,"type":112},"2025-11-19",{"date":116,"type":101},"2026-11-30",{"name":5,"class":6},1]