[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07273188":3,"trial-entities:NCT07273188":99,"trial-summary:NCT07273188":103},{"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":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":43,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":17,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":66,"locations":69,"central_contacts":88,"overall_officials":93,"references":97,"see_also_links":98},"NCT07273188","25-008885","68Ga-FAPI-46 PET\u002FCT for Assessing Small Bowel Fibrostenosis in Crohn's Disease","Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study Designed to Illuminate the Spectrum of Fibrostenosis in Patients With Small Bowel Crohn's Disease","RECRUITING","2027-04-30","2026-02","2026-02-09","2026-01-26","Mayo Clinic","OTHER",true,"This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. The goal is to determine whether areas of early or developing fibrosis (\"pre-stricture\" changes) demonstrate uptake of the tracer, which binds to fibroblast activation protein (FAP).\n\nParticipants with small bowel Crohn's disease will be assigned to either a case or control group based on CT or MR enterography findings at enrollment.\n\nCases will include participants who have a small bowel stricture or probable stricture, with or without penetrating complications.\n\nControls will include participants with small bowel Crohn's disease without strictures. Controls may have active inflammatory disease, luminal narrowing, or no active inflammation (including postoperative or chronic changes), as long as no stricture is present.\n\nBecause most radiologic strictures represent more advanced fibrostenosis, the study aims to enroll a larger proportion of controls to better characterize early fibrotic changes. Approximately one-third to one-half of participants will be cases, and the remainder controls. This design will allow comparison of FAPI uptake patterns in patients with and without strictures to understand how FAP expression relates to the development of small bowel fibrosis.",null,[19,20,21,22],"Crohn's Disease","Intestinal Fibrosis","Inflamatory Bowel Disease","Intestinal Strictures Related to Crohn´s Disease",[24,25,26,27,28,29],"Ga68-FAPI-46","PET\u002FCT","Small bowel stricture","Fibrostenosis","FAPI PET","Small bowel Crohn's disease","INTERVENTIONAL","DIAGNOSTIC",[33],"EARLY_PHASE1",{"count":35,"type":36},45,"ESTIMATED",[38],{"type":39,"name":24,"description":40,"armGroupLabels":41},"DRUG","Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV",[42],"A group of participants getting PET\u002FCT scan with 68Ga-FAPI-46",[44,47],{"measure":45,"timeFrame":46},"Completion of PET\u002FCT with Ga68-FAPI-46 by all participants","Through study completion, an average of 2 years",{"measure":48,"description":49,"timeFrame":46},"Number of participants completing PET\u002FCT with Ga68-FAPI-46","Participants complete PET\u002FCT with Ga68-FAPI-46",[],"ALL","18 Years",false,{"inclusion":55,"exclusion":62,"raw_text":65},[56,57,58,59,60,61],"Known small bowel Crohn's disease","Research or clinical MR enterography, or clinical CT enterography, within 3 months.","Male or female with age greater than 18 years old.","Diagnosis of Crohn's disease by a gastroenterologist","Willingness to undergo 68Ga-FAPI-46 PET\u002FCT","Subjects with the capacity to give informed consent and willingness to provide written consent",[63,64],"Pregnant and\u002For breast-feeding subjects.","Hypersensitivity to any excipients in 68Ga-FAPI-46","Inclusion Criteria:\n\n* Known small bowel Crohn's disease\n* Research or clinical MR enterography, or clinical CT enterography, within 3 months.\n* Male or female with age greater than 18 years old.\n* Diagnosis of Crohn's disease by a gastroenterologist\n* Willingness to undergo 68Ga-FAPI-46 PET\u002FCT\n* Subjects with the capacity to give informed consent and willingness to provide written consent\n\nExclusion Criteria:\n\n* Pregnant and\u002For breast-feeding subjects.\n* Hypersensitivity to any excipients in 68Ga-FAPI-46",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":13,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":85},"Rochester","Minnesota","55905","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Bruce S Lee, Ph.D.","CONTACT","507-538-4446","lee.yong@mayo.edu",{"name":82,"role":78,"phone":83,"email":84},"Bruce L Will","507-266-0111","will.brian@mayo.edu",{"lat":86,"lon":87},44.02163,-92.4699,[89,91],{"name":90,"role":78,"phone":83,"email":84},"Brian Will",{"name":92,"role":78,"phone":79,"email":80},"Yong S Lee",[94],{"name":95,"affiliation":13,"role":96},"David J Bartlett","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Crohn Disease",[],{"nct_id":4,"found":15,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is a prospective, case-control study that will compare participants with and without small bowel strictures. It aims to enroll 45 participants.","completed","68Ga-FAPI-46 PET\u002FCT for Crohn's Disease Fibrosis","This study is looking at whether a special imaging scan, called a PET\u002FCT, using a substance called 68Ga-FAPI-46, can find areas of scarring (fibrosis) in the small bowel of people with Crohn's disease. The goal is to see if this scan can detect early signs of scarring, even before strictures (narrowing of the bowel) fully develop. You might be able to join if you are over 18, have small bowel Crohn's disease, and have had a recent MRI or CT scan of your intestines. The study will consider it a success if all participants complete the PET\u002FCT scan with 68Ga-FAPI-46. The current status of this study is unclear, and it plans to enroll 45 participants.","Participants will be followed through study completion, which is an average of 2 years.",115,"You would undergo a 68Ga-FAPI-46 PET\u002FCT scan. The study completion is expected to average 2 years.","Not stated in the trial record.",[],"v2"]