[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441388":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":28,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":28,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":41,"whyStopped":28,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"A","EXPERIMENTAL","Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV",[13],"Radiation: MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)",{"label":15,"type":10,"description":16,"interventionNames":17},"B","ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT), if a biologically effective dose (BED) of ≥ 100 Gy is achievable using an ITV",[18],"Radiation: ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)",{"label":20,"type":10,"description":21,"interventionNames":22},"C","Magnetic Resonance-guided Stereotactic Body Radiotherapy (MRgSBRT). If a BED of ≥ 100 Gy cannot be achieved using an ITV concept (e.g. due to OAR constraints), patients will be treated in arm C using MRgSBRT with the highest achievable dose as deemed appropriate by the treating radiation oncologist",[13],[24,29],{"type":25,"name":26,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)",[15],null,{"type":25,"name":30,"description":30,"armGroupLabels":31,"otherNames":28},"MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)",[9,20],[33],{"name":34,"role":35,"phone":36,"phoneExt":28,"email":37},"Jakob Liermann, PD Dr","CONTACT","+496221 56","jakob.liermann@med.uni-heidelberg.de",[39],{"facility":40,"status":41,"city":42,"state":28,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University Hospital of Heidelberg, Radiation Oncology","RECRUITING","Heidelberg","69120","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],8.69079,49.40768,{"lat":50,"lon":49},[53],{"name":54,"role":55,"phone":28,"phoneExt":28,"email":28},"Jürrgen Debus, MD PHD","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Juergen Debus","Department Head","100441388","phase-2-magnetic-resonance-guided-adaptive-stereotactic-body-radiotherapy-for-hepatic-metastases-100441388",false,"NCT05027711","Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases","Magnetic Resonance-guided Adaptive Stereotactic Body Radiotherapy for Hepatic Metastases - MAESTRO -","MAESTRO","Inclusion Criteria:\n\n* confirmed underlying solid malignant tumor (no germ cell tumor, leukemia, lymphoma)\n* 1-3 hepatic metastases confirmed by pre-therapeutic MRI\n* indication for SBRT of 1-3 hepatic metastases\n* maximum diameter each hepatic metastasis ≤ 5 cm (in case of 3 metastases: sum of diameters ≤ 12 cm)\n* age ≥ 18 years of age\n* Karnofsky Performance Score ≥ 60%\n* ability to lie still on the radiotherapy treatment couch for at least one hour\n* ability to hold one's breath for more than 25 seconds\n* for women with childbearing potential, adequate contraception\n* ability of subject to understand character and individual consequences of the clinical trial\n* written informed consent (must be available before enrolment in the trial)\n\nExclusion Criteria:\n\n* refusal of the patients to take part in the study\n* patients with primary liver cancer (eg. HCC, CCC)\n* patients after liver transplantation\n* impairment of liver function to an extent contraindicating radiotherapy (to the discretion of the treating radiation oncologist)\n* active acute hepatic\u002Fbiliary infection (e.g. hepatitis, cholangitis, cholecystitis)\n* previous radiotherapy of the hepatobiliary system, if previous and current target volumes overlap MAESTRO Study Studienprotokoll Seite 25 von 54 Version 1.0 vom 17.12.2020\n* patients who have not yet recovered from acute toxicities of prior therapies\n* claustrophobia\n* pregnant or lactating women\n* contraindications against performing contrast-enhanced MRI scans (pacemakers, other implants making MRI impossible, allergy to gadolinium (GD)-based contrast agent)\n* participation in another competing clinical study or observation period of competing trials","ALL","18 Years",{"count":70,"type":71},90,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","Stereotactic body radiotherapy (SBRT) is an established local treatment method for patients with hepatic oligometastases. Liver metastases often occur in close proximity to radiosensitive organs at risk (OARs). This limits the possibility to apply sufficiently high doses needed for optimal local control. MR-guided radiotherapy (MRgRT) is expected to hold potential to improve hepatic SBRT by offering superior soft-tissue contrast for enhanced target identification as well as the benefit of daily real-time adaptive treatment. The MAESTRO trial therefore aims to assess the potential advantages of adaptive, gated MR-guided SBRT (MRgSBRT) compared to conventional SBRT at a standard linac using an ITV (internal target volume) approach (ITV-SBRT).",[77],"Hepatic Metastasis",[79],"Magentic Resonance-guided Adaptive Stereotactic Body Radiotherapy","2026-03-06",{"date":82,"type":83},"2026-03-10","ACTUAL",{"date":85,"type":83},"2021-08-12",{"date":87,"type":71},"2030-01-31",{"name":5,"class":6},1]