Nctid:
NCT06224985
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000013", "term"=>"Congenital Abnormalities"}], "browseLeaves"=>[{"id"=>"M12", "name"=>"Congenital Abnormalities", "asFound"=>"Malformations", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>131}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2016-04-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2021-04-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-27", "studyFirstSubmitDate"=>"2024-01-03", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-04-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Images produced by General Electrics' 3 Tesla MRI", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Nerve network in areas of interest (pelvis) using tractography analysis with 3 Tesla MRI by automation of 3D imaging using images produced by General Electrics' 3 Tesla MRI. This automation will be carried out using software developed by Telecom Paristech."}], "secondaryOutcomes"=>[{"measure"=>"Post-operative consequences of surgery and/or rehabilitation treatment in patients with abdomino-pelvic tumours or pelvic malformations.", "timeFrame"=>"through study completion, an average of 1 year"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Malformation", "Tumor", "Paediatric Surgery", "3D Imaging"]}, "descriptionModule"=>{"briefSummary"=>"This study is part of the launch of a multidisciplinary project called IMAG2, for image-guided minimally invasive surgery. It involves collaboration between the radiology and surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at the LTCI at Télécom ParisTech.\n\nTo make a decision, surgeons need access to a 3D model reflecting the anatomy of the specific patient and its pathological variations. Patient-specific 3D reconstruction provides a significant improvement, leading to a precise assessment of the malformation or tumour and its relationship with surrounding organs, nerves and vessels. It allows the surgeon to simulate a pre-operative procedure, which is a definite advantage in terms of safe, effective and curative surgery, particularly in oncology. MRI has been chosen as the basic imaging technique because of its non-irradiating nature and the current lack of 3D MRI reconstruction technology.\n\nThe study aims to provide an aid to diagnosis and surgical planning by developing dedicated methods and algorithms for segmenting not only the tumour but also the main anatomical components surrounding the tumour from 3D MRI imaging data. The imaging will be performed on a 3 Tesla MRI. The data will be that required for diagnosis and surgical planning, acquired on a routine clinical basis with an expected benefit for patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"5 months", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients included in the three groups are followed in the visceral surgery department of Necker-Enfants Malades Hospital in Paris (France) for whose an MRI is required as part of diagnosis, extension assessment or monitoring.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"To be included, patients must meet the following criteria:\n\n* Patient aged between 5 months and 17 years\n* Patient with a confirmed diagnosis of :\n\n * Abdomino-pelvic tumour\n * Pelvic malformation\n* Patient whose parents or legal guardians have read, accepted and signed the study consent form\n* Patients whose parents or legal guardians are beneficiaries of a social security scheme.\n\nTo be included, control patients (patients other than those suffering from an abdomino-pelvic tumour or malformation) must meet the following criteria:\n\n* Patient aged between 5 months and 17 years inclusive.\n* A patient being followed in the visceral surgery department for a pathology other than tumour or malformation, and requiring MRI as part of his or her diagnosis, extension assessment or monitoring.\n* Patient whose parents or legal guardians have read, accepted and signed the study consent form.\n* Patient whose parents or guardians are beneficiaries of a social security scheme.\n\nNon inclusion criteria :\n\nPatients\n\n* Patient with a contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical cardiac valve, old vascular clips on cerebral aneurysm, etc.\n* Patient having participated in a therapeutic clinical trial involving a new molecule in the 30 days prior to inclusion.\n\nControls :\n\n* Patient with a contraindication to MRI: ocular metallic foreign body, pacemaker, cardiac mechanical valve, old vascular clips on cerebral aneurysm, etc.\n* Patient having participated in a therapeutic clinical trial involving a new molecule in the 30 days prior to inclusion."}, "identificationModule"=>{"nctId"=>"NCT06224985", "acronym"=>"IMAG2", "briefTitle"=>"Computational Anatomy in Surgery for Childhood Tumours and Malformations", "organization"=>{"class"=>"OTHER", "fullName"=>"Imagine Institute"}, "officialTitle"=>"Computational Anatomy in Surgery for Childhood Tumours and Malformations", "orgStudyIdInfo"=>{"id"=>"IMAG 2"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Malformation"}, {"label"=>"Tumors"}, {"label"=>"Controls"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75015", "city"=>"Paris", "state"=>"Ile De France", "country"=>"France", "facility"=>"Necker enfants malades Hospital", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Imagine Institute", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
