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

• ClinicalTrials.gov Identifier: NCT03640637
• Recruitment Status: Enrolling by invitation
• First Posted: August 21, 2018
• Last Update Posted: April 27, 2020
• Sponsor: Odense University Hospital
• Collaborator: University of Southern Denmark
• Information provided by (Responsible Party): Steffen Husby, Odense University Hospital

Study Description

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.

Condition or disease
Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Accuracy of PET/MRI in Diagnosis and Treatment Evaluation of Children and Adolescents With Inflammatory Bowel Disease
• Actual Study Start Date: October 18, 2018
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: August 2021

Groups and Cohorts

Group/Cohort
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Sensitivity, specificity, accuracy and predictive value of PET/MRI at diagnosis of IBD and in differentiating Crohn's disease and Ulcerous colitis. [ Time Frame: 6 months ]

   PET/MRI will be compared to standard evaluation: Clinical symptom scoring systems (for Crohns disease: wPCDAI, for Ulcerous colitis: PUCAI), faecal calprotectin, C-reactive protein and endoscopy with histology.

   Endoscopy will be used for gold reference. PET/MRI scans will be analysed for PET uptake values pr. bowel segment for each patient and compared to standard evaluation results.

2. Sensitivity, specificity and accuracy of PET/MRI in diagnosing disease flare in Crohn's disease and to evaluate inflammatory response to anti-TNF treatment. [ Time Frame: 1 month ]

   PET/MRI will be compared to standard evaluation: Clinical symptom scoring systems (wPCDAI), faecal calprotectin, C-reactive protein and endoscopy with histology.

   The patient will serve as his/her own control. This will be a pilot study. PET/MRI scans will be analysed for PET uptake values pr. bowel segment for each patient and compared to standard evaluation results.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children (aged 8-17) referred from general practice to pediatric evaluation for IBD at tertiary centres, either H. C. Andersens Childrens Hospital, Odense University Hospital or Department of Pediatrics, Lillebaelt Hospital OR children with known Crohn's disease about to start anti-TNF therapy.

Adolescents (aged 18-25) referred from general practice to evaluation for IBD at the Department of Gastroenterology, Odense University Hospital OR adolescents about to start anti-TNF therapy.

Newly diagnosed patient, who start anti-TNF therapy at inclusion will be included in both studies.

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.

Contacts and Locations

Locations

Denmark

Steffen Husby

Odense, Denmark, DK-5000

Sponsors and Collaborators

Odense University Hospital

University of Southern Denmark

Investigators

• Principal Investigator: Steffen Husby, Professor; Odense University Hospital

More Information

• Responsible Party: Steffen Husby, Professor, MD, DMSc, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT03640637
• Other Study ID Numbers: OUH-HCA-003
• First Posted: August 21, 2018
• Last Update Posted: April 27, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Project data management plan is still being developed.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Steffen Husby, Odense University Hospital:

Positron emission tomography; Magnetic resonance imaging

Additional relevant MeSH terms:

Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases