An observational study in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by Odense University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 8 Years to 25 Years. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Odense University Hospital · Observational
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
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.
1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.
This study's planned enrollment of 75 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Sensitivity, specificity, accuracy and predictive value of PET/MRI at diagnosis of IBD and in differentiating Crohn's disease and Ulcerous colitis.
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.
Time frame: 6 months
Sensitivity, specificity and accuracy of PET/MRI in diagnosing disease flare in Crohn's disease and to evaluate inflammatory response to anti-TNF treatment.
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.
Time frame: 1 month
Plan to share: Undecided — Project data management plan is still being developed.
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This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Odense University Hospital