Crohn DiseaseNCT00587210
Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel
An observational study of Crohn Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastroenteroloy Clinic; Inflammatory Bowel Disease Clinic
Who may be able to join
- Known or suspected Crohn Disease
- Undergoing colonoscopy and CT enterography
Who cannot join
- Contraindication to MR
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel.
Read the detailed description
Crohn Disease is an inflammatory condition that involves the small bowel. Patients usually undergo multiple imaging exams in the diagnosis and surveillance of the disease. CT has been shown to have excellent results for detecting active inflammation. In the United States MR has lagged behind CT in utilization for imaging the small bowel. An advantage of MR over CT is the lack of radiation exposure to the patient. A new oral contrast agent is available that provides good distension of the small bowel and allows improved identification of active inflammation. The purpose of this study is to compare the accuracy of MR to CT using this new oral contrast agent and to assess exam quality.
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
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 or known Crohn Disease | Suspected or known Crohn Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
exam quality
Measured: one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionDec 2008
- Study completionDec 2008
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 Mayo ClinicThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Fidler, Mayo Clinic
- Investigators
- Jeff L Fidler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587210
- Sponsor's protocol ID
- 381-04
- Status last verified
- Jan 2016
- First submitted
- 21 Dec 2007
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel
- ClinicalTrials.gov ID
- NCT00587210
- Acronym / sponsor ID
- 381-04
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2008 (estimated)
- 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 assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel.
Detailed description
Crohn Disease is an inflammatory condition that involves the small bowel. Patients usually undergo multiple imaging exams in the diagnosis and surveillance of the disease. CT has been shown to have excellent results for detecting active inflammation. In the United States MR has lagged behind CT in utilization for imaging the small bowel. An advantage of MR over CT is the lack of radiation exposure to the patient. A new oral contrast agent is available that provides good distension of the small bowel and allows improved identification of active inflammation. The purpose of this study is to compare the accuracy of MR to CT using this new oral contrast agent and to assess exam quality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected or known Crohn Disease | – | –Suspected or known Crohn Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastroenteroloy Clinic; Inflammatory Bowel Disease Clinic
Key inclusion criteria (2 listed)
- Known or suspected Crohn Disease
- Undergoing colonoscopy and CT enterography
Key exclusion criteria (1 listed)
- Contraindication to MR
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
exam quality
Time frame: one time point
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 22 Jan 2016.
- 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.
Jeff L Fidler, MD principal investigator
Mayo Clinic
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, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 1 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 22 Jan 2016. 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 United States. 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?
exam quality (time frame: one time point). 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 22 Jan 2016.