Crohn DiseaseNCT03096379
MRI Differentiating Gut TB and Crohn's
An observational study of Crohn Disease and Intestinal Tuberculosis, run by The University of Hong Kong at 1 site in China.
Trial summary
It is clinically challenging to differentiate Crohn's disease from gut tuberculosis especially in regions endemic of tuberculosis infection. The investigators plan to perform magnetic resonance enterography (MRE) who presented to our hospital in Shenzhen, China for new onset of lower gastrointestinal symptoms and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease, Intestinal Tuberculosis
- What is being tested?
- Magnetic resonance imaging
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2014to 30 Mar 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with new-onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.
Who may be able to join
- New-onset lower gastrointestinal symptoms of less than 3 months
- Ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.
- No prior tuberculosis treatment
- No prior immunomodulatory or anti-tumor necrosis factor treatment
Who cannot join
- Stage 4 or 5 chronic kidney disease, i.e. a glomerular filtration rate of <=30 ml/min.
- Contraindications to magnetic resonance imaging, including the installation of metallic devices or implants in-situ (e.g. pacemakers)
- Prior intestinal resection
- Known concomitant chronic small / large bowel disease, including ulcerative colitis, eosinophilic gastroenteritis, NSAID-related enterography etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differentiating Gut Tuberculosis and Crohn's Disease Via Magnetic Resonance Enterography
It is clinically challenging to differentiate Crohn's disease from gut tuberculosis especially in regions endemic of tuberculosis infection. The investigators plan to perform magnetic resonance enterography (MRE) who presented to our hospital in Shenzhen, China for new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy. MRE findings will be independently interpreted by two radiologistsThe role of MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.
Read the detailed description
The clinical presentation of gut tuberculosis and Crohn's disease is very similar. In areas endemic of tuberculosis infection, differentiating the two diseases remains difficult. Both disease entities can have similar clinical, endoscopic and histological findings. Yet, wrongly diagnosing gut tuberculosis as Crohn's disease can potentially result in disastrous outcomes, especially when anti-tumor necrosis factor therapy, an important therapeutic option for Crohn's disease, can result in fulminant reactivation of tuberculosis.
Magnetic resonance enterography (MRE) is emerging as a effective imaging modality in evaluating the disease status of Crohn's disease. MRE, unlike computed tomography, emits no radiation, and is suitable for repeated serial imaging in younger-age populations. Ulcerations, strictures, transmural enhancement and mesenteric combing of the small bowel can be clearly demonstrated via MRE in Crohn's disease. Yet, the utilization of MRE in diagnosing gut tuberculosis remains largely unexplored. Whether MRE can be used to differentiate gut tuberculosis from Crohn's disease remains unknown.
The investigators plan to consecutively recruit 150 patients presenting to our hospital in Shenzhen, China, for new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.All recruited participants will undergo MRE, to be performed on a 1.5 Tesla scanner (Magnetom Avanto, Siemens Healthcare, Erlangen, Germany). MRE findings will be independently interpreted by two radiologists with special expertise in abdominal MR imaging and blinded to the patients' clinical data. The relationship between radiological patterns and clinical, endoscopic and histological findings will be analyzed. The role of MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.
- Conditions
- Crohn Disease, Intestinal Tuberculosis
- Being tested
- Magnetic resonance imaging
- Keywords
- TB, CD, MRE, ileocecal
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Enterography performed via magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging | Patients with new-onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy. Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small / large bowel transmural enhancement
Via magnetic resonance enterography independently interpreted by two radiologist with expertise
Measured: During procedure
Secondary outcomes (3)
Skip lesions in small / large bowel
Via magnetic resonance enterography independently interpreted by two radiologist with expertise
Measured: During procedure
Vascular engorgement
Via magnetic resonance enterography independently interpreted by two radiologist with expertise
Measured: During procedure
Mesenteric combing
Via magnetic resonance enterography independently interpreted by two radiologist with expertise
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start30 Dec 2014
- Primary completion30 Dec 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital
- Responsible party
- Principal investigator, Wai-Kay Seto, The University of Hong Kong
- Investigators
- Wai-Kay Seto, MD, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096379
- Sponsor's protocol ID
- MRE-TB-CD
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating Gut Tuberculosis and Crohn's Disease Via Magnetic Resonance Enterography
- ClinicalTrials.gov ID
- NCT03096379
- Acronym / sponsor ID
- MRE-TB-CD
- Conditions
- Crohn Disease, Intestinal Tuberculosis
- Keywords
- TB, CD, MRE, ileocecal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital
- Study start
- 30 Dec 2014 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 30 Mar 2017 (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.
It is clinically challenging to differentiate Crohn's disease from gut tuberculosis especially in regions endemic of tuberculosis infection. The investigators plan to perform magnetic resonance enterography (MRE) who presented to our hospital in Shenzhen, China for new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy. MRE findings will be independently interpreted by two radiologistsThe role of MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.
Detailed description
The clinical presentation of gut tuberculosis and Crohn's disease is very similar. In areas endemic of tuberculosis infection, differentiating the two diseases remains difficult. Both disease entities can have similar clinical, endoscopic and histological findings. Yet, wrongly diagnosing gut tuberculosis as Crohn's disease can potentially result in disastrous outcomes, especially when anti-tumor necrosis factor therapy, an important therapeutic option for Crohn's disease, can result in fulminant reactivation of tuberculosis.
Magnetic resonance enterography (MRE) is emerging as a effective imaging modality in evaluating the disease status of Crohn's disease. MRE, unlike computed tomography, emits no radiation, and is suitable for repeated serial imaging in younger-age populations. Ulcerations, strictures, transmural enhancement and mesenteric combing of the small bowel can be clearly demonstrated via MRE in Crohn's disease. Yet, the utilization of MRE in diagnosing gut tuberculosis remains largely unexplored. Whether MRE can be used to differentiate gut tuberculosis from Crohn's disease remains unknown.
The investigators plan to consecutively recruit 150 patients presenting to our hospital in Shenzhen, China, for new onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.All recruited participants will undergo MRE, to be performed on a 1.5 Tesla scanner (Magnetom Avanto, Siemens Healthcare, Erlangen, Germany). MRE findings will be independently interpreted by two radiologists with special expertise in abdominal MR imaging and blinded to the patients' clinical data. The relationship between radiological patterns and clinical, endoscopic and histological findings will be analyzed. The role of MRE in distinguishing gut tuberculosis from Crohn's disease will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging | – | Diagnostic Test: Magnetic resonance imagingPatients with new-onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with new-onset of lower gastrointestinal symptoms and ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.
Key inclusion criteria (4 listed)
- New-onset lower gastrointestinal symptoms of less than 3 months
- Ileocecal mucosal lesions of uncertain diagnosis as evidenced by the presence of inflammation, ulceration, strictures or nodules on colonoscopy.
- No prior tuberculosis treatment
- No prior immunomodulatory or anti-tumor necrosis factor treatment
Key exclusion criteria (4 listed)
- Stage 4 or 5 chronic kidney disease, i.e. a glomerular filtration rate of <=30 ml/min.
- Contraindications to magnetic resonance imaging, including the installation of metallic devices or implants in-situ (e.g. pacemakers)
- Prior intestinal resection
- Known concomitant chronic small / large bowel disease, including ulcerative colitis, eosinophilic gastroenteritis, NSAID-related enterography etc.
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 |
|---|---|---|
| Magnetic resonance imagingEnterography performed via magnetic resonance imaging | Diagnostic test | Magnetic resonance imaging |
Primary outcome
Small / large bowel transmural enhancement
Time frame: During procedure
Via magnetic resonance enterography independently interpreted by two radiologist with expertise
3 secondary outcomes
Skip lesions in small / large bowel
Time frame: During procedure
Vascular engorgement
Time frame: During procedure
Mesenteric combing
Time frame: During procedure
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 17 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Wai-Kay Seto, MD principal investigator
The University of Hong Kong-Shenzhen 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 Crohn Disease and Intestinal Tuberculosis, run by The University of Hong Kong at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 17 Apr 2019. 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 China. 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?
Small / large bowel transmural enhancement (time frame: During procedure). 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 17 Apr 2019; AzTrials last refreshed its copy on 1 Nov 2026.