NCT03340519Completed
Early MRI Prediction of Crohns
Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
The investigators plan a prospective study designed to optimize and translate noncontrast, novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal inflammation as well as for allowing early prediction of response to medical therapy in small bowel Crohn's Disease (CD).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 35 (actual)
- First submitted
- 9 Nov 2017
- Start date
- 17 Dec 2018
- Primary completion date
- 25 Oct 2021
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Crohn's disease
- NCT number
- NCT03340519
What you commit to
- Study type: Observational
- Participants enrolled: 35
- From 17 Dec 2018 to the primary completion date, 25 Oct 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to MRI (e.g., MRI incompatible implant or support device),
- Previous (remote) diagnosis or treatment of inflammatory bowel disease or other intestinal disease,
- Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.
- Newly Diagnosed Crohns Group
- Contraindication to MRI (e.g., MRI incompatible implant or support device),
- Previous (remote) diagnosis or treatment of inflammatory bowel disease,
- Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.
Other illness
- History of intra-abdominal surgery, including surgery on the intestine,
- History of intra-abdominal surgery, including surgery on the intestine,
- Known bleeding disorder/coagulopathy (contraindication for adult subjects, as this may increase the risk of research colonoscopy),
Other
- Healthy Control Group
- Inability to obtain assent/consent,
- Inability to tolerate 45 minutes in an MRI scanner,
- Inability to obtain assent/consent,
- Inability to tolerate 45 minutes in an MRI scanner,
Who the study is looking for
- Healthy Control Group
- -Be able to tolerate up to 45 minutes in an MRI scanner
- Newly Diagnosed Crohns Group
- Newly diagnosed, pathology-confirmed diagnosis of small bowel Crohn's disease,
- Expected to receive infliximab (Remicade; Janssen Biotech, Inc.) or other anti-Tumor Necrosis Factor (anti-TNF) medical therapy,
- Between 11 to 25 years of age and able to assent/consent,
- Be available for follow-up MRI at 4-weeks and 6-months after the initiation of treatment,
- Be able to tolerate up to 45 minutes in an MRI scanner.
Age in the registry: 11 years to 25 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.