Crohn DiseaseNCT03435016
A Comparative Study of MRI, US and CE for Assessing Treatment Response in Known Crohn's Disease
A study testing Diagnostic work-up in people with Crohn Disease, run by Sygehus Lillebaelt at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease. 1. Comparing imaging modalities: The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Diagnostic work-up
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 1 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An established diagnosis of CD
- Age > 18 years
- Ileocolonoscopy: Endoscopically active CD (SES-CD ≥ 3)
- Clinically active CD (Harvey-Bradshaw Index ≥ 5 or Crohn's Disease Activity Index ≥ 150)
- Clinical indication for medical treatment with corticosteroids or biological therapy
- Signed informed consent
Who cannot join
- Acute bowel obstruction
- Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
- Pregnancy or lactation
- Alcohol or drug abuse
- Known gastrointestinal disorder other than inflammatory bowel disease
- Renal failure defined by a plasma-creatinine above the normal reference range
Show all 9Show fewer
- Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
- Interpreter required or inability to understand the oral and written information
- Bowel surgery performed between pre- and post-treatment assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Magnetic Resonance Imaging, Ultrasound and Capsule Endoscopy of the Small and Large Intestine for Assessing Treatment Response in Known Crohn's Disease
The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease.
- Comparing imaging modalities: The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer healing after medical treatment in patients with symptomatic Crohn's disease compared to ileocolonoscopy.
- Sensitivity and specificity for ulcer healing
- Changes in activity parameters for SBCCE, MREC and US before and after medical treatment.
- Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease.
- Treatment induced bowel wall alterations visualized with ultrasound:
- A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease.
- Changes in bowel wall thickness, vascularity and elastography parameters, and time to normalization of the bowel wall.
Read the detailed description
The aim of this study is to evaluate the applicability of SBCCE, MREC and US for diagnosing ulcer healing after medical treatment in patients with symptomatic CD compared to the current gold standard (ileocolonoscopy).
This is a prospective, blinded, multicenter study. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, SBCCE, MREC and US before and 10-12 weeks after medical treatment with corticosteroids or biological therapy (Infliximab, Adalimumab, Vedolizumab or Ustekinumab). All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing SBCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities. Ileocolonoscopy serves as the diagnostic gold standard, and endoscopic disease activity is assessed with SES-CD.
LOGISTICS: Patients go through an accelerated diagnostic work-up at inclusion and after 10-12 weeks of medical treatment. In patients undergoing their first diagnostic work-up, ileocolonoscopy with biopsies is performed last to avoid false positive lesions at SBCCE. In patients with an established diagnosis, examinations can be performed in a random order provided that tissue samples are not taken during ileocolonoscopy. All diagnostic procedures should be completed within two weeks. If one imaging modality is contraindicated it is classified as "not performed". If ileocolonoscopy (gold standard) is contraindicated, the patient is excluded from the study. All radiological examinations are performed in the Department of Radiology, Lillebaelt Hospital Vejle. Ileocolonoscopy and SBCCE are performed at the local gastroenterology department.
During the pre- and post-treatment assessment, radiological examinations and SBCCE are analyzed by physicians blinded to the result of ileocolonoscopy and the other bowel examinations. However, at the post-treatment assessment, physicians are not blinded to the pre-treatment examinations. After completing all diagnostic procedures, the treating gastroenterologist is provided with the results of SBCCE, MREC and US.
EXTENDED ULTRASOUND STUDY: Patients are scheduled for additional US procedures after 2 and 4 weeks. Procedures are performed without blinding, i.e. the physician is aware of the results of the pre-treatment assessment and the preceding US examinations. If the bowel wall normalizes at week 2, the subsequent procedure is cancelled. Fecal calprotectin is measured before each US procedure.
- Conditions
- Crohn Disease
- Being tested
- Diagnostic work-up
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic work-upDiagnostic test
Also called Ileocolonoscopy, MR enterocolonography, Ultrasound, Small bowel colon capsule endoscopy
Patients are examined with all modalities. MR enterocolonography, ultrasound, and small bowel capsule endoscopy are compared against ileocolonoscopy (gold standard).
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis | Other | Not described Receives: Diagnostic Test: Diagnostic work-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Sensitivity and specificity of SBCCE, MREC and US for the diagnosis of ulcer healing in the terminal ileum and colon
Measured: 8-10 weeks
Secondary outcomes (5)
Diagnostic accuracy fCal
Sensitivity and specificity of fecal calprotectin for the diagnosis of ulcer healing in the terminal ileum and colon
Measured: 8-10 weeks
Diagnostic accuracy CRP
Sensitivity and specificity of C-reactive protein for the diagnosis of ulcer healing in the terminal ileum and colon
Measured: 8-10 weeks
Bowel wall thickening
Changes of bowel wall thickening (mm) assessed with US under medical treatment of Crohn's disease
Measured: 8-10 weeks
Elastography
Changes of shear wave elastography (m/s) assessed with US under medical treatment of Crohn's disease
Measured: 8-10 weeks
Ultrasound activity index
Changes of Limberg score assessed with US under medical treatment of Crohn's disease
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Feb 2018
- Primary completion1 Mar 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Principal investigator, Michael Dam Jensen, Sygehus Lillebaelt
- Investigators
- Michael D Jensen, MD, PhD, Principal investigator, Lillebaelt Hospital Vejle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435016
- Sponsor's protocol ID
- ANDI-2
- Status last verified
- Nov 2023
- First submitted
- 2 Feb 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be available to other researchers.
Publications
Brodersen JB, Rafaelsen SR, Nejatbakhsh E, Jensen MD. Assessment of transmural treatment response in known Crohn's disease: a prospective blinded study of the intermodality agreement between intestinal ultrasound and magnetic resonance enterography. BMJ Open Gastroenterol. 2026 Feb 9;13(1):e002175. doi: 10.1136/bmjgast-2025-002175.
PubMed 41663130
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Magnetic Resonance Imaging, Ultrasound and Capsule Endoscopy of the Small and Large Intestine for Assessing Treatment Response in Known Crohn's Disease
- ClinicalTrials.gov ID
- NCT03435016
- Acronym / sponsor ID
- ANDI-2
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 15 Feb 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 aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease.
- Comparing imaging modalities: The applicability of small bowel colon capsule endoscopy (SBCCE), magnetic resonance enterocolonography (MREC) and ultrasound (US) for diagnosing ulcer healing after medical treatment in patients with symptomatic Crohn's disease compared to ileocolonoscopy.
- Sensitivity and specificity for ulcer healing
- Changes in activity parameters for SBCCE, MREC and US before and after medical treatment.
- Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease.
- Treatment induced bowel wall alterations visualized with ultrasound:
- A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease.
- Changes in bowel wall thickness, vascularity and elastography parameters, and time to normalization of the bowel wall.
Detailed description
The aim of this study is to evaluate the applicability of SBCCE, MREC and US for diagnosing ulcer healing after medical treatment in patients with symptomatic CD compared to the current gold standard (ileocolonoscopy).
This is a prospective, blinded, multicenter study. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, SBCCE, MREC and US before and 10-12 weeks after medical treatment with corticosteroids or biological therapy (Infliximab, Adalimumab, Vedolizumab or Ustekinumab). All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing SBCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities. Ileocolonoscopy serves as the diagnostic gold standard, and endoscopic disease activity is assessed with SES-CD.
LOGISTICS: Patients go through an accelerated diagnostic work-up at inclusion and after 10-12 weeks of medical treatment. In patients undergoing their first diagnostic work-up, ileocolonoscopy with biopsies is performed last to avoid false positive lesions at SBCCE. In patients with an established diagnosis, examinations can be performed in a random order provided that tissue samples are not taken during ileocolonoscopy. All diagnostic procedures should be completed within two weeks. If one imaging modality is contraindicated it is classified as "not performed". If ileocolonoscopy (gold standard) is contraindicated, the patient is excluded from the study. All radiological examinations are performed in the Department of Radiology, Lillebaelt Hospital Vejle. Ileocolonoscopy and SBCCE are performed at the local gastroenterology department.
During the pre- and post-treatment assessment, radiological examinations and SBCCE are analyzed by physicians blinded to the result of ileocolonoscopy and the other bowel examinations. However, at the post-treatment assessment, physicians are not blinded to the pre-treatment examinations. After completing all diagnostic procedures, the treating gastroenterologist is provided with the results of SBCCE, MREC and US.
EXTENDED ULTRASOUND STUDY: Patients are scheduled for additional US procedures after 2 and 4 weeks. Procedures are performed without blinding, i.e. the physician is aware of the results of the pre-treatment assessment and the preceding US examinations. If the bowel wall normalizes at week 2, the subsequent procedure is cancelled. Fecal calprotectin is measured before each US procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis | Other | Diagnostic Test: Diagnostic work-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An established diagnosis of CD
- Age > 18 years
- Ileocolonoscopy: Endoscopically active CD (SES-CD ≥ 3)
- Clinically active CD (Harvey-Bradshaw Index ≥ 5 or Crohn's Disease Activity Index ≥ 150)
- Clinical indication for medical treatment with corticosteroids or biological therapy
Key exclusion criteria (9 listed)
- Acute bowel obstruction
- Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
- Pregnancy or lactation
- Alcohol or drug abuse
- Known gastrointestinal disorder other than inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic work-upAlso: Ileocolonoscopy, MR enterocolonography, Ultrasound, Small bowel colon capsule endoscopyPatients are examined with all modalities. MR enterocolonography, ultrasound, and small bowel capsule endoscopy are compared against ileocolonoscopy (gold standard). | Diagnostic test | Diagnosis |
Primary outcome
Diagnostic accuracy
Time frame: 8-10 weeks
Sensitivity and specificity of SBCCE, MREC and US for the diagnosis of ulcer healing in the terminal ileum and colon
5 secondary outcomes
Diagnostic accuracy fCal
Time frame: 8-10 weeks
Diagnostic accuracy CRP
Time frame: 8-10 weeks
Bowel wall thickening
Time frame: 8-10 weeks
Elastography
Time frame: 8-10 weeks
Ultrasound activity index
Time frame: 8-10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 41663130Brodersen JB, Rafaelsen SR, Nejatbakhsh E, Jensen MD. Assessment of transmural treatment response in known Crohn's disease: a prospective blinded study of the intermodality agreement between intestinal ultrasound and magnetic resonance enterography. BMJ Open Gastroenterol. 2026 Feb 9;13(1):e002175. doi: 10.1136/bmjgast-2025-002175.
- Individual participant dataSharing planned: Yes. Individual participant data will not be available to other researchers.
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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.
Michael D Jensen, MD, PhD principal investigator
Lillebaelt Hospital Vejle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic work-up in people with Crohn Disease, run by Sygehus Lillebaelt 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 28 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy (time frame: 8-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435016, which also lists 1 linked publication.
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 28 Nov 2023.