Ulcerative Colitis Clinical Trial
Official title:
Accuracy of PET/MRI in Diagnosis and Treatment Evaluation of Children and Adolescents With Inflammatory Bowel Disease
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05702879 -
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
|
||
| Not yet recruiting |
NCT05953402 -
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
|
||
| Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
| Recruiting |
NCT03950232 -
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
| Completed |
NCT03124121 -
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
|
Phase 4 | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Withdrawn |
NCT04209556 -
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
|
Phase 2 | |
| Terminated |
NCT00061282 -
Clotrimazole Enemas for Pouchitis in Children and Adults
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
|
N/A | |
| Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
|
Phase 4 | |
| Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
|
||
| Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
|
Phase 2 | |
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
| Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
|
Phase 2 | |
| Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
|
Phase 2 |