The Role of PET/MRI in the Diagnosis and Treatment of Children and Adolescents With Inflammatory Bowel Diseases

NCT ID: NCT03640637

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2021-08-31

Brief Summary

The purpose of this study is to test the utility of PET/MRI in diagnosis and management of Inflammatory bowel disease (IBD) in children and adolescents, hereby

• To test if PET/MRI scan is an accurate method to diagnose and differentiate Crohn's disease and Ulcerous Colitis in children and adolescents suspected of IBD.
• To evaluate whether PET/MRI scan in children and adolescents with Crohn's disease is an accurate method to diagnose relapses and to monitor the effect of biological treatment with monoclonal antibodies directed towards Tumor Necrosis Factor-alpha.

Detailed Description

Crohn's disease and Ulcerous Colitis constitute the primary inflammatory bowel diseases. Crohn's disease can affect any part of the digestive tract, from mouth to anus, and inflammation can be present in all layers of the intestinal wall. Ulcerous Colitis is primarily located in the inner layer of the colonic bowel wall.

In the pediatric population, current diagnostic strategies involve blood tests, fecal sampling (calprotectin), magnetic resonans (MRI) scan and both upper and lower endoscopies. In this population endoscopy requires general anesthesia and involves the risk of bowel wall perforation.

A known method of identifying inflammation is by Positron Emission Tomography (PET). In this procedure a radioactively labelled sugar molecule is injected into the blood stream via a venous catheter. The inflammatory cells take op relatively more of the sugar, compared to normal cells, and the cells are visible on the scan. Until now the anatomic localization of the inflammation has been poor but recently is has become possible to combine the MRI scan with PET resulting in excellent localization, with minimal radiation exposure (corresponding to 1 year background radiation in Denmark).

To make diagnosis and identification of inflammation flares during treatment safer for children and adolescents we aim to investigate whether PET/MRI is accurate in diagnosing IBD in children and adolescents and in diagnosing flares in children with Crohn's disease.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suspected IBD

A prospective study of 50 pediatric patients suspected of IBD. Participants will undergo routine diagnostic procedures for evaluation of pediatric IBD including blood samples, faecal samples, endoscopies (colonoscopy and gastroscopy with biopsy/histology) and MRI of the abdomen. In addition, a PET scan will be performed in this protocol and combined with MRI. For accuracy measures, PET/MRI scan will be compared to the combined findings of endoscopy, histology and severity of inflammation by clinical scoring systems (weighted Pediatric Crohn's Disease Activity Index (wPCDAI) for CD and Pediatric Ulcerative Colitis activity Index (PUCAI) for CU), faecal calprotectin and biochemistry.

No interventions assigned to this group

Treatment response group

A pilot study of 10-15 patients previously diagnosed with CD who will undergo PET/MRI scan as an investigational procedure before initiation of biological treatment with an anti-TNF-alpha antibody (infliximab, adalimumab) because of disease relapse or steroid dependent disease. Patients will be scheduled for a PET/MRI again after one month. This study will evaluate if PET/MRI can diagnose a flare in CD and if PET/MRI is a reliable imaging tool to monitor intestinal inflammation. In this study the patient will act as his/her own control.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Suspected of having IBD
• Planned to undergo standard evaluation OR
• Known Crohn's disease about to start anti-TNF therapy due to steroid dependency or disease relapse.

Exclusion Criteria

• Active or prior diagnosis of inflammatory disease other than IBD
• Active or prior diagnosis of cancer
• Type 1 diabetes
• Not able to lie still for the MRI scan.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steffen Husby

Professor, MD, DMSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steffen Husby, Professor

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Steffen Husby

Odense, , Denmark

Countries

Denmark

Other Identifiers

OUH-HCA-003

Identifier Type: -

Identifier Source: org_study_id