[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509322":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":10,"responsibleParty":33,"collaborators":35,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":10,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients",null,"Patients with ABCD1 pathogenic variant",[13],"Device: brainQuant module of brainTale-care platform",{"label":15,"type":10,"description":16,"interventionNames":10},"Healthy volunteers","Healthy volunteers inclusion in order to calibrate the MRI machine used and its settings.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DEVICE","brainQuant module of brainTale-care platform","brainQuant is a software module of brainTale-care medical device (a medical device software as a service (web platform) ) for the automatic processing of brain diffusion Magnetic resonance images and the provision of the diffusion regional standardised parameters.",[9],[24],{"name":25,"affiliation":26,"role":27},"Fanny MOCHEL, MD, PhD","APHP - Pitié-Salpêtrière Hospital","PRINCIPAL_INVESTIGATOR",[29],{"name":25,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+33157274482","fanny.mochel@upmc.fr",{"type":34,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[36],{"name":37,"class":38},"Braintale","INDUSTRY","100509322","validation-of-a-prognostic-biomarker-using-brain-diffusion-mri-in-x-linked-adrenoleukodystrophy-100509322",false,"NCT05911919","Validation of a Prognostic Biomarker Using Brain Diffusion MRI in X-linked Adrenoleukodystrophy","CALDIFF","Patients:\n\nInclusion criteria\n\n* \\> 18 years old\n* Male gender\n* Genetically diagnosed with ALD by carrying an ABCD1 pathogenic variant\n* Signed written informed consent\n* Affiliation to a social security regime (patient with AME cannot be included)\n\nExclusion criteria\n\n* Patient with non-arrested CALD\n* Other neurological conditions such as brain tumour, stroke or a traumatic head injury\n* Contraindication to MRI (claustrophobia, implanted metal components in the head, panic disorder, epilepsy)\n* People under legal protection measure (tutorship, curatorship or safeguard measures)\n* Patient included in another interventional clinical trial\n\nHealthy volunteers\n\nInclusion criteria\n\n* Male or female subject from 18 to 65 years old\n* In general good health condition\n* Signed written informed consent\n* Affiliation to a social security regime (healthy volunteers with AME cannot be enrolled)\n\nExclusion criteria\n\n* People under legal protection measure (tutorship, curatorship or safeguard measures)\n* Contraindication to MRI (claustrophobia, implanted metal components in the head, panic disorder, epilepsy)\n* History of previous brain disease (including but not limited to cranial trauma in the last 12 months, glioma, stroke, neurodegenerative diseases)\n* Arterial hypertension as defined in WHO criteria\n* Volunteer included in another interventional clinical trial\n* Pregnancy and breastfeeding women",true,"ALL","18 Years",{"count":50,"type":51},200,"ESTIMATED","OBSERVATIONAL","CALD is an inflammatory demyelinating disease that causes severe motor and cognitive deficit leading to rapid death. Hematopoietic stem cell transplantation (HSCT) can halt neuroinflammation in CALD through the replacement of microglia (i.e., brain immune system) but only if performed during its early phase.\n\nUsing standard brain MRI, it is estimated that only 30% of adult CALD patients are identified. Complex and lengthy clinical evaluations together with MRI reading from experts improve CALD detection but are not available in routine clinical practice.\n\nDiffusion tensor imaging is a quantitative microstructural technique that can identify neuroinflammation at a very early stage. Still, its implementation in clinical practice has been very limited due to high inter-center measurements variability and bias due to data quality issues. The approach we will use solves these problems by introducing an automatic calibration and standardization with systematic quality control enabling the use of all MRI scanners in clinical settings.\n\nThe innovative aspect of this project lies on the validation of an expert-independent prognosis biomarker able to specifically identify patients at high-risk to convert to CALD so that treatment can be initiated at the early stage of neuroinflammation.\n\nWe aim to demonstrate that this tool has at least a 2-fold sensitivity compared to the current standard of care.",[55],"X-linked Adrenoleukodystrophy",[57,58,59,60,61,62,63,64],"Cerebral adrenoleukodystrophy (CALD)","adrenomyeloneuropathy (AMN)","ABCD1","MRI","Diffusion Tensor Imaging (DTI)","Brain-Quant","Male","Adult","NOT_YET_RECRUITING","2023-06-30",{"date":68,"type":69},"2023-07-03","ACTUAL",{"date":71,"type":51},"2023-09",{"date":73,"type":51},"2028-09",{"name":5,"class":6}]