Developing the Pediatric MR Enterography-based Damage Index in Crohn's disease (pMEDIC) and the Pediatric Inflammatory Crohn's MRE Index (PICMI) - ImageKids

Shaare Zedek Medical Center0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•- Children from age 5 (under 18 years of age) with established diagnosis of Crohn's disease involving any location, by the presence of accepted clinical, radiologic, endoscopic and histological criteria
•- enrolment at the time of performing ileocolonoscopy and esophageal-gastroduodenoscopy (EGD) as part of clinical care for any reason
•- Children will be enrolled at any phase of the disease (at diagnosis and thereafter as required clinically). In order to ensure enough subjects with intestinal damage and since damage is progressing over time, enrolment will be stratified based on disease duration. Enrolment for each stratum of disease duration will be closed after reaching the expected sample size
•* 20% of enrolment children will be within 3 months of diagnosis
•* 20% of children will be between 3 months and 2 years
•* 20% will be 2 to 3 years
•* 40% will have disease duration over 3 years
•- Children may be enrolled in any disease activity state, Pediatric Crohn's Disease Activity Index (PCDAI) between 0 and 100.

•- Young children requiring anesthesia for the MRE because of lack of cooperation will be excluded (since the enteric contrast cannot be administered during the 2 hours before anesthesia and it is crucial that the contrast be given just prior the test)
•- For the first 120 children only, subjects who are not expected to be available for 18 months follow-up, will be excluded (the last 120 subjects may be enrolled as they are not followed longitudinally)

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