Inflammatory Bowel DiseasesPEDICADNCT03640637
The Role of PET/MRI in the Diagnosis and Treatment of Children and Adolescents With Inflammatory Bowel Diseases
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Oct 2018to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Positron emission tomography, Magnetic resonance imaging
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start18 Oct 2018
- Primary completionDec 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Steffen Husby, Odense University Hospital
- Investigators
- Steffen Husby, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640637
- Sponsor's protocol ID
- OUH-HCA-003
- Acronym
- PEDICAD
- Status last verified
- Apr 2020
- First submitted
- 15 Aug 2018
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Project data management plan is still being developed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of PET/MRI in Diagnosis and Treatment Evaluation of Children and Adolescents With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03640637
- Acronym / sponsor ID
- PEDICAD / OUH-HCA-003
- Keywords
- Positron emission tomography, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: Undecided. Project data management plan is still being developed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Husby, Professor principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.