[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100401503":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":49,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Crohn Disease",null,"This group will be 46 adolescents, ages 13-20, who have been recently (within 3 months) diagnosed with Crohn Disease.\n\nAll participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.",[13,14,15,16],"Diagnostic Test: Coronal T1 weighted spin echo images","Diagnostic Test: Spin-lattice relaxation (T1)","Diagnostic Test: Magnetic resonance spectroscopy","Diagnostic Test: Blood Draw",{"label":18,"type":10,"description":19,"interventionNames":20},"Control","Controls will be matched for age, Tanner staging, and BMI percentile.\n\nAll participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.",[13,14,15,16],[22,27,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DIAGNOSTIC_TEST","Coronal T1 weighted spin echo images","Coronal T1 weighted spin echo images will be obtained through the knee with a field of view of 16cm to include distal femoral and proximal tibial metaphyses.",[18,9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Spin-lattice relaxation (T1)","Spin-lattice relaxation (T1) relaxometry acquisition consisting of seven fast spin echo (FSE) acquisitions through the knee. T1 maps from the T1 relaxometry images will be generated using a two-parameter-fit iterative algorithm developed in-house using IDL software (Harris Geospatial Solutions, Melbourne, FL, USA). Mean T1 values for each region will be recorded. The anatomical locations of these regions will be consistent in size for all subjects and location. The locations chosen for the primary endpoints are ones that are known to be rich in red and yellow marrow, respectively.",[18,9],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Magnetic resonance spectroscopy","Magnetic resonance spectroscopy. MRS will be performed within a 1 mL voxel situated in the medial aspect of the distal femoral metaphysis. A single voxel point resolved spectral acquisition (PRESS) technique will be used to acquire non-water suppressed spectra at echo times of 20, 30, 40, and 50 ms using 32 signal averages per echo time with a TR of 2.5 s (total scan time = 5.4 minutes). Spectral fits using JMRUI MRS processing software (www.jmrui.eu) to the water and methylene\u002Fmethyl resonances will be used to quantify peak areas and establish T2 corrected fat\u002F(fat + water) ratios.",[18,9],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Blood Draw","Blood draw. Blood draws will be used to attain and assess markers of bone formation\u002Fresorption and to perform immune studies. Specific markers of bone formation that will be assessed include osteocalcin (OC) and procollagen type 1 N-terminal propeptide (P1NP), and a marker of bone resorption, c-telopeptide (CTX). We will also evaluate molecular gene signatures from the blood samples that correlate with the previously described bone imaging phenotypes. At that point, the information will be used to develop a CyTOF panel to evaluate differences in immune cellular populations between CD patients with normal versus low BMD, and matched controls.",[18,9],[40],{"name":41,"affiliation":42,"role":43},"Rebecca Gordon, MD","Boston Children's Hospital","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":10,"email":48},"CONTACT","(617) 355-7476","rebecca.gordon@childrens.harvard.edu",[50],{"facility":42,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-71.05977,42.35843,{"lat":61,"lon":60},[64],{"name":41,"role":46,"phone":10,"phoneExt":10,"email":10},{"type":43,"investigatorFullName":41,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Rebecca Gordon, MD Attending Physician, Division of Pediatric Endocrinology, MGH; Assistant Professor of Pediatrics, Harvard Medical School","100401503","skeletal-health-and-bone-marrow-composition-in-newly-diagnosed-adolescents-with-crohn-disease-100401503",false,"NCT04508088","Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease","Inclusion Criteria:\n\n* Crohn's Disease diagnosed within the past 3 months, or a healthy, matched control\n\nExclusion Criteria:\n\n* Participants with chronic disease known to affect skeletal metabolism\n* Participants on certain medications within the prior 3 months that are known to affect skeletal metabolism\n* Participants who are pregnant\n* Participants who have a history of: claustrophobia, internal body metal that is not compatible with MRI machine, or a known abnormality on or adjacent to the left knee",true,"ALL","13 Years","20 Years",{"count":78,"type":79},92,"ESTIMATED","OBSERVATIONAL","The investigators will be evaluating bone marrow composition via magnetic resonance imaging in newly diagnosed adolescents with Crohn disease (CD) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry and peripheral quantitative computed tomography. This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with newly diagnosed CD exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including bone turnover markers and immune cellular\u002Fmolecular parameters.",[83,9],"Inflammatory Bowel Disease",[85,86,87,88,89],"Crohn","Bone Marrow","Dual-energy X-ray absorptiometry","Peripheral Quantitative Computed Tomography","Magnetic Resonance Imaging","2025-10-28",{"date":92,"type":93},"2025-10-30","ACTUAL",{"date":95,"type":93},"2020-09-10",{"date":97,"type":79},"2026-12",{"name":5,"class":6},1]