Crohn's DiseaseNCT06533228
Helmsley 3.0: Abbreviated MRE
An observational study of Crohn's Disease, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and adults
Who may be able to join
- Established Crohn's disease diagnosis in patients 10 and older
- Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below
- Staging/ restaging/ follow- up of intestinal inflammation
- Evaluation of known or suspected luminal narrowing/ stricturing disease
- Evaluation of known or suspected internal penetrating disease
Who cannot join
- Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established
- New Crohn's disease diagnosis, undergoing baseline imaging
- Isolated colonic disease
- Known or suspected pregnancy
- Contraindication to magnetic resonance imaging (MRI)
- Ileostomy or prior ileal resection
Show all 9Show fewer
- Less than 10 years of age
- Unable or unwilling to follow imaging procedures
- Non- English speaking
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone
New York, New York, 10016
Nalini Jeet, 212-263-0228, Nalini.Jeet@nyulangone.org
Bari Dane
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Kristin Fritz, 507-293-0925, yaggy.Kristin@mayo.edu
Jeff Fidler
About this study
Official title: Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease
The purpose of our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.
Read the detailed description
This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.
The abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).
- Conditions
- Crohn's Disease
- Being tested
- Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)
- Keywords
- Magnetic Resonance Imaging (MRI), Crohn's Disease, Magnetic Resonance Enterography (MRE)
- 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 Imaging (MRI) or Magnetic Resonance Enterography (MRE)Diagnostic test
Abbreviated magnetic resonance enterography (MRE) imaging to detect active inflammation in patient's with known Crohn's Disease.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease Patients | Children and adults, who are scheduled for a clinical magnetic resonance enterography (MRE) to evaluate staging/ restaging of Crohn's disease, will be approached to undergo our novel abbreviated MRE. No intervention, observation only, perform MRE, and complete trade-off tolerance survey. Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare clinical MRE with research MRE
Our abbreviated magnetic resonance enterography (MRE) will be non-inferior to a standard clinical MRE in detecting small bowel inflammation, strictures and penetrating disease associated with Crohn's Disease.
Measured: 3 years
Secondary outcomes (2)
Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.
Patients/patients parents will answer a survey to determine if the abbreviated magnetic resonance enterography (MRE) or the clinical MRE is preferred.
Measured: 3 years
Willingness to trade diagnostic performance for patient experience
We will ask patients a series of questions to determine their tolerance for trading diagnostic performance for a better patient experience.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2024
- Primary completion28 Feb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Dillman, Principal investigator, CCHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533228
- Sponsor's protocol ID
- 2024-0086
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06533228
- Acronym / sponsor ID
- 2024-0086
- Conditions
- Crohn's Disease
- Keywords
- Magnetic Resonance Imaging (MRI), Crohn's Disease, Magnetic Resonance Enterography (MRE)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 1 Aug 2024 (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 our study is to compare an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) protocol to a conventional, standard of care MRE in children and adults with Crohn's Disease.
Detailed description
This multi-center study will evaluate the effectiveness of an abbreviated magnetic resonance imaging (MRI) of the bowel or magnetic resonance enterography (MRE) to document the presence and severity of small bowel inflammation, the presence and features of stricturing and penetrating disease in children and adults with Crohn's Disease.
The abbreviated MRI of the bowel or MRE will not involve IV contrast or an injection of glucagon and water will replace the oral contrast used in standard of care MREs. Scan time will be greatly reduced with the abbreviated MRE ( approximately 15 minutes) compared to a standard of care MRE (approximately 60 minutes).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease Patients | – | Diagnostic Test: Magnetic Resonance Imaging (MRI) or Magnetic Resonance Enterography (MRE)Children and adults, who are scheduled for a clinical magnetic resonance enterography (MRE) to evaluate staging/ restaging of Crohn's disease, will be approached to undergo our novel abbreviated MRE. No intervention, observation only, perform MRE, and complete trade-off tolerance survey. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults
Key inclusion criteria (5 listed)
- Established Crohn's disease diagnosis in patients 10 and older
- Undergoing clinical magnetic resonance enterography (MRE) examinations for any reason(s) below
Key exclusion criteria (9 listed)
- Undergoing initial imaging for suspected Crohn's disease where the diagnosis of Crohn's disease has yet to be definitively established
- New Crohn's disease diagnosis, undergoing baseline imaging
- Isolated colonic disease
- Known or suspected pregnancy
- Contraindication to magnetic resonance imaging (MRI)
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 Imaging (MRI) or Magnetic Resonance Enterography (MRE)Abbreviated magnetic resonance enterography (MRE) imaging to detect active inflammation in patient's with known Crohn's Disease. | Diagnostic test | Crohn's Disease Patients |
Primary outcome
Compare clinical MRE with research MRE
Time frame: 3 years
Our abbreviated magnetic resonance enterography (MRE) will be non-inferior to a standard clinical MRE in detecting small bowel inflammation, strictures and penetrating disease associated with Crohn's Disease.
2 secondary outcomes
Patient experiences and preferences between the abbreviated MRE and the standard clinical MRE.
Time frame: 3 years
Willingness to trade diagnostic performance for patient experience
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
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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.
Jonathan Dillman principal investigator
CCHMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Children's Hospital Medical Center, Cincinnati at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanita Dean ((513) 803-0853, Tanita.Dean@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare clinical MRE with research MRE (time frame: 3 years). 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 Oct 2025.