[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573400":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":175,"collaborators":10,"id":177,"slug":178,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":179,"sex":184,"minAge":185,"maxAge":10,"enrollmentInfo":186,"targetDuration":10,"studyType":189,"phases":10,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"MRIguidance B.V.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Spinal MRI and CT",null,"Subjects referred to the radiology department for an MRI and CT scan of the spine having symptoms related to a spine disorder with suspected underlying involvement of osseous structures, will be asked to participate in this study.",[13],"Device: BoneMRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","BoneMRI","BoneMRI is a quantitative 3D MRI technique,capable of generating CT-like, quantitative radiodensity bone MRI images to visualize cortical and trabecular bone, allowing to assess bone structure and morphology, in addition to regular clinical MRI images.",[9],[21],{"name":22,"affiliation":23,"role":24},"Peter R Seevinck, dr. ir.","iCEO, Founder","STUDY_DIRECTOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","00316 81741711","peter.seevinck@mriguidance.com",{"name":31,"role":27,"phone":10,"phoneExt":10,"email":32},"Hilde Geraedts, phd","clinical@mriguidance.com",[34,51,64,77,92,107,120,134,147,160],{"facility":35,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"UZ Gent","RECRUITING","Ghent","9000","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],3.71667,51.05,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":10,"phoneExt":10,"email":50},"Lennart Jans","lennart.jans@ugent.be",{"facility":52,"status":36,"city":53,"state":10,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"UZ Leuven","Leuven","3000",{"type":42,"coordinates":56},[57,58],4.70093,50.87959,{"lat":58,"lon":57},[61],{"name":62,"role":27,"phone":10,"phoneExt":10,"email":63},"Bart Depreitere, Prof. dr.","bart.depreitere@uzleuven.be",{"facility":65,"status":36,"city":66,"state":10,"zip":67,"country":39,"countryCode":40,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"VITAZ","Sint-Niklaas","9100",{"type":42,"coordinates":69},[70,71],4.1437,51.16509,{"lat":71,"lon":70},[74],{"name":75,"role":27,"phone":10,"phoneExt":10,"email":76},"Johan van Goethem, Prof. dr.","johan.vangoethem@vitaz.be",{"facility":78,"status":36,"city":79,"state":10,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hopital saint joseph","Marseille","13008","France","FR",{"type":42,"coordinates":84},[85,86],5.38107,43.29695,{"lat":86,"lon":85},[89],{"name":90,"role":27,"phone":10,"phoneExt":10,"email":91},"Kenny Rozenfeld, Dr.","krozenfeld@hopital-saint-joseph.fr",{"facility":93,"status":36,"city":94,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"UMC Utrecht","Utrecht","3584 CX","Netherlands","NL",{"type":42,"coordinates":99},[100,101],5.12222,52.09083,{"lat":101,"lon":100},[104],{"name":105,"role":27,"phone":10,"phoneExt":10,"email":106},"P R Seevinck, Dr. Ir","p.seevinck@umcutrecht.nl",{"facility":108,"status":36,"city":109,"state":10,"zip":110,"country":96,"countryCode":97,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Amsterdam UMC","Amsterdam","1105AZ",{"type":42,"coordinates":112},[113,114],4.88969,52.37403,{"lat":114,"lon":113},[117],{"name":118,"role":27,"phone":10,"phoneExt":10,"email":119},"M Maas, Prof. MD. PhD","m.maas@amsterdamumc.nl",{"facility":121,"status":122,"city":123,"state":10,"zip":124,"country":96,"countryCode":97,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Leids universitair medisch center","NOT_YET_RECRUITING","Leiden","2333ZA",{"type":42,"coordinates":126},[127,128],4.49306,52.15833,{"lat":128,"lon":127},[131],{"name":132,"role":27,"phone":10,"phoneExt":10,"email":133},"K van Langevelde, Dr.","K.van_Langevelde@lumc.nl",{"facility":135,"status":36,"city":136,"state":10,"zip":137,"country":96,"countryCode":97,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Erasmus MC","Rotterdam","3015 GD",{"type":42,"coordinates":139},[140,141],4.47917,51.9225,{"lat":141,"lon":140},[144],{"name":145,"role":27,"phone":10,"phoneExt":10,"email":146},"E HG Oei, Prof. Dr.","e.oei@erasmusmc.nl",{"facility":148,"status":36,"city":149,"state":10,"zip":150,"country":96,"countryCode":97,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Elisabeth Tweesteden Ziekenhuis","Tilburg","5022GC",{"type":42,"coordinates":152},[153,154],5.0913,51.55551,{"lat":154,"lon":153},[157],{"name":158,"role":27,"phone":10,"phoneExt":10,"email":159},"Ruth Geuze, Dr.","r.geuze@etz.nl",{"facility":161,"status":36,"city":162,"state":10,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Kantonsspital st. gallen","Sankt Gallen","9007","Switzerland","CH",{"type":42,"coordinates":167},[168,169],9.37477,47.42391,{"lat":169,"lon":168},[172],{"name":173,"role":27,"phone":10,"phoneExt":10,"email":174},"Martin N Stienen, PD Dr.","martin.stienen@kssg.ch",{"type":176,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100573400","clinical-validation-of-bonemri-in-the-spine-100573400",false,"NCT06745791","Clinical Validation of BoneMRI in the Spine","CleverBones","Inclusion Criteria:\n\n* ≥ 12 years old\n* Indication for diagnostic MRI of the spine\n* Indication for diagnostic CT of the spine\n* Eligible for MRI\n* Eligible for CT\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* History of (psychiatric) disorder which causes the patient to be incompetent to make a thought-out decision\n* claustrophobia\n* \\>3 months between CT and MRI scan","ALL","12 Years",{"count":187,"type":188},450,"ESTIMATED","OBSERVATIONAL","BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline. The BoneMRI technology is capable of generating CT-like, quantitative radiodensity bone MRI images to visualize cortical and trabecular bone, allowing to assess bone structure and morphology, in addition to regular clinical MRI images. The use of BoneMRI has been investigated and clinically validated in multiple musculoskeletal studies involving the cervical spine, hip and sacro-iliac joint. In order to clinically use BoneMRI in the entire spine, the BoneMRI technology needs to be validated in that area as well, focussing on geometrical and voxelwise accuracy of the radiodensity contrast to assure accurate visualization of the osseous structures. As robustness against expected data variability between hospitals is crucial for successful machine learning algorithms, multiple MR field strengths and scanner types from different manufacturers will be included in this study. If successful, BoneMRI will facilitate a better, easier and cheaper workflow by enabling diagnosis, treatment planning and surgical navigation using a single radiological examination, without the potential hazards of ionizing radiation.",[192,193,194],"Bone Diseases","Image","Medical Device",[196,197,198,199],"medical device","software","synthetic CT","MRI sequence","2025-09-23",{"date":202,"type":203},"2025-09-24","ACTUAL",{"date":205,"type":203},"2021-08-20",{"date":207,"type":188},"2026-12-31",{"name":5,"class":6},10]