[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598049":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":54,"collaborators":20,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous injection of ferumoxytol as off-label MRI contrast agent for tracking of macrophages","EXPERIMENTAL","ImmunoMRI for tracking of TAMs will be integrated into 18F-FDG-PET\u002FMRI scans that are performed for routine clinical purposes -i.e., assessment of disease extent before, and response assessment after\u002Fon treatment- to minimize patient discomfort and improve compliance.\n\nImmunoMRI will be based on an iron sensitive fat-suppressed, fast spoiled gradient echo T2\\* mapping sequence, obtained before and after intravenous injection of the iron oxide nanoparticle ferumoxytol (commerical name: Feraheme).\n\nFor each patient immunoMRI will be performed twice: before treatment, and 3-4 weeks after start of treatment (CAR T cells or bispecific antibodies).",[13],"Drug: MRI contrast-enhancing agents",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","MRI contrast-enhancing agents","1. Ferumoxytol will be injected as an off-label MRI contrast agent at a dose of 4 mg\u002Fkg body mass. For safety (in accordance with prior research), ferumoxytol will be diluted 1:4 in saline, and administered slowly over at least 15 minutes, with patient monitoring during and post injection.\n2. ImmunoMRI will be performed using an iron sensitive fat-suppressed, fast spoiled gradient echo T2\\* mapping sequence. At each time point (i.e. pre-treatment and post-treatment), T2\\* mapping will be performed before and \\~24h after ferumoxytol injection.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Marius E Mayerhoefer, MD, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+436642046495, +16469615030","marius.mayerhoefer@meduniwien.ac.at",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Lucian Beer, MD","+4314040048180","lucian.beer@meduniwien.ac.at",[35],{"facility":5,"status":20,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Vienna","State of Vienna","1090","Austria","AT",{"type":42,"coordinates":43},"Point",[44,45],16.37208,48.20849,{"lat":45,"lon":44},[48,50,51],{"name":23,"role":27,"phone":49,"phoneExt":20,"email":29},"+436642046495",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Philipp Staber, MD, PhD","SUB_INVESTIGATOR",{"type":24,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Marius Mayerhoefer","Professor, Principal Investigator","100598049","early-phase-1-immunomri-for-assessment-of-tumor-associated-macrophages-100598049",false,"NCT07066436","ImmunoMRI for Assessment of Tumor-associated Macrophages","ImmunoMRI for Assessment of Tumor-associated Macrophages: A Prospective Study in Patients With Diffuse Large B-cell Lymphoma Receiving CAR T-cell or Bispecific Antibody Therapy","Inclusion Criteria:\n\n1. Pathology-proven relapsed\u002Frefractory DLBCL\n2. Evidence of at least one anatomic site of tumor involvement on most recent prior imaging, e.g. CT, MRI, PET, or ultrasound, reflecting R\u002FR DLBCL.\n3. Ability to understand the study goals or outline and to give written informed consent.\n\nExclusion Criteria:\n\n1. Clinically confirmed pregnancy for women, or breast-feeding women; for pre-menopausal women who do not use hormonal contraception, a pregnancy test with a negative result will be required.\n2. Age below the specified minimum of 18 years.\n3. Any type of anemia at baseline (due to potentially altered ferumoxytol uptake)\n4. Impaired renal function \u002F renal insufficiency\n5. Known contraindication to MRI (per MRI Safety Guidelines, or conditions such as claustrophobia)\n6. Known hypersensitivity to ferumoxytol or any of its components, or history of allergic reaction to any intravenous iron product.","ALL","18 Years",{"count":67,"type":68},60,"ESTIMATED","INTERVENTIONAL",[71],"EARLY_PHASE1","About 35% of patients with a type of blood cancer called diffuse large B-cell lymphoma don't respond well to standard treatment or their cancer comes back. When this happens, newer treatments like CAR T-cell therapy (using modified immune cells) or bispecific antibodies (special proteins that help the immune system fight cancer) are an option. However, these treatments are only successful in about half the patients. It is currently difficult to predict which patients will respond to these treatments or experience serious side effects. This makes it hard to choose the best treatment plan for a given patient.\n\nIn this project, a special type of magnetic resonance imaging (MRI) scan will be used to track immune cells called macrophages that live around tumors. These cells can either help fight cancer or help cancer grow. By understanding how these cells behave, it may be possible to predict treatment success. The MRI technique involves injecting an iron-based substance called ferumoxytol, which can be used as an MRI contrast agent, into patients' veins. This contrast agent gets absorbed by the macrophages, making them visible on MRI scans throughout the entire body - not just one tumor spot. Sixty patients will be scanned before and after treatment (30 getting CAR T-cells, 30 getting bispecific antibodies), and results will be compared with tissue samples.\n\nThe goals are to predict which patients will go into complete remission, predict who will survive longer without cancer progression, and identify patients at risk for serious side effects like cytokine release syndrome. If successful, this imaging technique could help to personalize treatment choices, potentially improving outcomes while avoiding unnecessary toxicity in patients who will not benefit from these intensive therapies.",[74],"DLBCL - Diffuse Large B Cell Lymphoma","NOT_YET_RECRUITING","2025-07-04",{"date":78,"type":79},"2025-07-15","ACTUAL",{"date":81,"type":68},"2025-10",{"date":83,"type":68},"2028-09",{"name":5,"class":6},1]