[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06533228":3,"trial-entities:NCT06533228":120,"trial-summary:NCT06533228":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":48,"minimum_age":49,"maximum_age":24,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":68,"locations":72,"central_contacts":105,"overall_officials":114,"references":118,"see_also_links":119},"NCT06533228","2024-0086","Helmsley 3.0: Abbreviated MRE","Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease","RECRUITING","2028-02","2025-10","2025-10-27","2024-09-01","Children's Hospital Medical Center, Cincinnati","OTHER",false,"The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.","This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.\n\nThe abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).",[19],"Crohn's Disease",[21,19,22],"Magnetic Resonance Imaging (MRI)","Magnetic Resonance Enterography (MRE)","OBSERVATIONAL",null,[],{"count":27,"type":28},300,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)","Abbreviated magnetic resonance enterography (MRE) imaging to detect active inflammation in patient's with known Crohn's Disease.",[35],"Crohn's Disease Patients",[37],{"measure":38,"description":39,"timeFrame":40},"Compare clinical MRE with research MRE","Our abbreviated magnetic resonance enterography (MRE) will be non-inferior to a standard clinical MRE in detecting small bowel inflammation, strictures and penetrating disease associated with Crohn's Disease.","3 years",[42,45],{"measure":43,"description":44,"timeFrame":40},"Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.","Patients\u002Fpatients parents will answer a survey to determine if the abbreviated magnetic resonance enterography (MRE) or the clinical MRE is preferred.",{"measure":46,"description":47,"timeFrame":40},"Willingness to trade diagnostic performance for patient experience","We will ask patients a series of questions to determine their tolerance for trading diagnostic performance for a better patient experience.","ALL","10 Years",{"inclusion":51,"exclusion":57,"raw_text":67},[52,53,54,55,56],"Established Crohn's disease diagnosis in patients 10 and older","Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below","Staging\u002F restaging\u002F follow- up of intestinal inflammation","Evaluation of known or suspected luminal narrowing\u002F stricturing disease","Evaluation of known or suspected internal penetrating disease",[58,59,60,61,62,63,64,65,66],"Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established","New Crohn's disease diagnosis, undergoing baseline imaging","Isolated colonic disease","Known or suspected pregnancy","Contraindication to magnetic resonance imaging (MRI)","Ileostomy or prior ileal resection","Less than 10 years of age","Unable or unwilling to follow imaging procedures","Non- English speaking","Inclusion Criteria:\n\n* Established Crohn's disease diagnosis in patients 10 and older\n* Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below\n\n  * Staging\u002F restaging\u002F follow- up of intestinal inflammation\n  * Evaluation of known or suspected luminal narrowing\u002F stricturing disease\n  * Evaluation of known or suspected internal penetrating disease\n\nExclusion Criteria:\n\n* Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established\n* New Crohn's disease diagnosis, undergoing baseline imaging\n* Isolated colonic disease\n* Known or suspected pregnancy\n* Contraindication to magnetic resonance imaging (MRI)\n* Ileostomy or prior ileal resection\n* Less than 10 years of age\n* Unable or unwilling to follow imaging procedures\n* Non- English speaking",[69,70,71],"CHILD","ADULT","OLDER_ADULT",[73,91],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":88},"Mayo Clinic","Rochester","Minnesota","55905","United States",[80,85],{"name":81,"role":82,"phone":83,"email":84},"Kristin Fritz","CONTACT","507-293-0925","yaggy.Kristin@mayo.edu",{"name":86,"role":87},"Jeff Fidler","PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},44.02163,-92.4699,{"facility":92,"status":8,"city":93,"state":93,"zip":94,"country":78,"contacts":95,"geoPoint":102},"NYU Langone","New York","10016",[96,100],{"name":97,"role":82,"phone":98,"email":99},"Nalini Jeet","212-263-0228","Nalini.Jeet@nyulangone.org",{"name":101,"role":87},"Bari Dane",{"lat":103,"lon":104},40.71427,-74.00597,[106,110],{"name":107,"role":82,"phone":108,"email":109},"Tanita Dean","(513) 803-0853","Tanita.Dean@cchmc.org",{"name":111,"role":82,"phone":112,"email":113},"Kristi Cole","(513)636-9403","kristi.barnett@cchmc.org",[115],{"name":116,"affiliation":117,"role":87},"Jonathan Dillman","CCHMC",[],[],{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Crohn Disease",[],{"nct_id":4,"found":125,"summary":126,"prompt_version":136},true,{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is an observational study with a planned enrollment of 300 participants. It compares a clinical MRE to a research MRE.","completed","Observational Study of Abbreviated MRE for Crohn's Disease","This study is looking at a new, shorter way to perform a Magnetic Resonance Enterography (MRE) scan, which is a special type of MRI that looks at your bowel. The goal is to see if this abbreviated MRE can detect active inflammation and other issues in people with Crohn's Disease as well as the standard, longer MRE. You might be able to join if you are 10 years or older, have a confirmed diagnosis of Crohn's Disease, and are already scheduled for a clinical MRE for reasons like checking inflammation or evaluating narrowing or fistulas. The study aims to compare the results of the clinical MRE with the research MRE over three years. The current recruitment status is unclear.","The primary comparison between the clinical MRE and research MRE will be measured at 3 years.",119,"You would undergo an abbreviated MRE imaging test, which takes about 15 minutes. This test uses water instead of oral contrast and does not involve IV contrast or glucagon injections.","Not stated in the trial record.",[],"v2"]