Helmsley 3.0: Abbreviated MRE
Observational · No treatment assigned · 2 sites · Children's Hospital Medical Center, Cincinnati
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 10 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2024-09-01.
- Main results expected around 2027-02-28 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- Compare clinical MRE with research MRE (3 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Enrollment | 300 (estimated) |
| Start date | 2024-09-01 |
| Primary completion (est.) | 2027-02-28 |
| First posted | 2024-08-01 |
| Last updated | 2025-10-27 |
| Official title | Comparison of Conventional Clinical and Abbreviated MR Enterography Protocols in Children and Adults With Crohn's Disease |
| ClinicalTrials.gov ID | NCT06533228 |
Interventions
- 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.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Less than 10 years of age * Unable or unwilling to follow imaging procedures * Non- English speaking
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic | Rochester, Minnesota | United States | Recruiting |
| NYU Langone | New York, New York | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.