Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials

Eileen Crowley; Christopher Ma; Leonard Guizzetti; Guangyong Zou; Peter J Lewindon; Michael S Gee; Jeffrey S Hyams; Michael J Rosen; Daniel von Allmen; Anthony de Buck van Overstraeten; Lisa M Shackelton; Julie Remillard; Lauren Schleicher; Jonathan R Dillman; Jordi Rimola; Stuart A Taylor; Joel G Fletcher; Peter C Church; Brian G Feagan; Anne M Griffiths; Vipul Jairath; Mary-Louise C Greer

doi:10.1093/ibd/izad134

Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials

Inflamm Bowel Dis. 2024 Mar 1;30(3):357-369. doi: 10.1093/ibd/izad134.

Authors

Eileen Crowley^{1

2}, Christopher Ma^{2

3

4}, Leonard Guizzetti², Guangyong Zou^{2

5}, Peter J Lewindon^{6

7}, Michael S Gee^{8

9}, Jeffrey S Hyams¹⁰, Michael J Rosen¹¹, Daniel von Allmen^{12

13}, Anthony de Buck van Overstraeten¹⁴, Lisa M Shackelton², Julie Remillard², Lauren Schleicher², Jonathan R Dillman^{15

16}, Jordi Rimola¹⁷, Stuart A Taylor¹⁸, Joel G Fletcher¹⁹, Peter C Church^{20

21}, Brian G Feagan^{2

5

22}, Anne M Griffiths²⁰, Vipul Jairath^{2

5

22}, Mary-Louise C Greer²³

Affiliations

¹ Department of Pediatrics, Division of Pediatric Gastroenterology, Children's Hospital Western Ontario, Western University, London Health Sciences Centre, London, Ontario, Canada.
² Alimentiv Inc, London, ON, Canada.
³ Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, AB, Canada.
⁴ Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
⁵ Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
⁶ Department of Gastroenterology, Queensland Children's Hospital, University of Queensland, Brisbane, Queensland, Australia.
⁷ Children's Medical Research Institute, University of Queensland, Brisbane, Queensland, Australia.
⁸ Department of Radiology, Massachusetts General Hospital Boston, MA, USA.
⁹ Department of Radiology, Harvard Medical School, Boston, MA, USA.
¹⁰ Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, Hartford, CT, USA.
¹¹ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Stanford Medicine, Stanford, CA, USA.
¹² Department of Pediatric Surgery and Surgical Services, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹³ Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹⁴ Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
¹⁵ Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹⁶ Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
¹⁷ IBD Unit, Radiology Department, Hospital Clinic Barcelona, IDIBAPS, Spain.
¹⁸ Centre for Medical Imaging, Charles Bell House, University College London, London, UK.
¹⁹ Department of Radiology, Mayo Clinic, Rochester, MN, USA.
²⁰ Division of Gastroenterology, Hepatology & Nutrition, Department of Paediatrics and IBD Centre, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
²¹ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
²² Department of Medicine, Division of Gastroenterology, Western University, London, ON, Canada.
²³ Department of Diagnostic Imaging, The Hospital for Sick Children, Department of Medical Imaging, University of Toronto, Toronto, ON, Canada.

PMID: 37524088
DOI: 10.1093/ibd/izad134

Abstract

Background: Perianal fistulas and abscesses occur commonly as complications of pediatric Crohn's disease (CD). A validated imaging assessment tool for quantification of perianal disease severity and activity is needed to evaluate treatment response. We aimed to identify magnetic resonance imaging (MRI)-based measures of perianal fistulizing disease activity and study design features appropriate for pediatric patients.

Methods: Seventy-nine statements relevant to MRI-based assessment of pediatric perianal fistulizing CD activity and clinical trial design were generated from literature review and expert opinion. Statement appropriateness was rated by a panel (N = 15) of gastroenterologists, radiologists, and surgeons using modified RAND/University of California Los Angeles appropriateness methodology.

Results: The modified Van Assche Index (mVAI) and the Magnetic Resonance Novel Index for Fistula Imaging in CD (MAGNIFI-CD) were considered appropriate instruments for use in pediatric perianal fistulizing disease clinical trials. Although there was concern regarding the use of intravascular contrast material in pediatric patients, its use in clinical trials was considered appropriate. A clinically evident fistula tract and radiologic disease defined as at least 1 fistula or abscess on pelvic MRI were considered appropriate trial inclusion criteria. A coprimary clinical and radiologic end point and inclusion of a patient-reported outcome were also considered appropriate.

Conclusion: Outcomes of treatment of perianal fistulizing disease in children must include MRI. Existing multi-item measures, specifically the mVAI and MAGNIFI-CD, can be adapted and used for children. Further research to assess the operating properties of the indices when used in a pediatric patient population is ongoing.

Keywords: Crohn’s disease; clinical trial; pediatric; pelvic MRI; perianal fistula.

Publication types

Review

MeSH terms

Abscess
Child
Clinical Trials as Topic
Crohn Disease* / complications
Crohn Disease* / diagnostic imaging
Fistula*
Humans
Magnetic Resonance Imaging

Supplementary concepts

Pediatric Crohn's disease