Early MRI Prediction of Crohns
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03340519 |
Recruitment Status :
Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : February 11, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Crohn Disease | Device: MR Imaging |
Study Type : | Observational |
Estimated Enrollment : | 35 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease |
Actual Study Start Date : | December 17, 2018 |
Actual Primary Completion Date : | October 25, 2021 |
Estimated Study Completion Date : | May 25, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Healthy Controls
Healthy Controls will undergo MR imaging to optimize MR techniques for bowel assessment and to acquire normative data
|
Device: MR Imaging
Novel MR imaging will be performed to provide bowel anatomic and functional data |
Newly Diagnosed Crohns Patients
MR imaging will be performed in newly diagnosed CD patients prior to initiation of infliximab therapy in order to obtain baseline measures in the setting of active intestinal inflammation
|
Device: MR Imaging
Novel MR imaging will be performed to provide bowel anatomic and functional data |
- Prediction of therapeutic response in patients with Crohns disease [ Time Frame: 30 minutes ]Assess novel MRI techniques for ability to predict early response to infliximab therapy in 20 newly diagnosed small bowel CD patients.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 11 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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.
Exclusion Criteria:
Healthy Control Group
- Inability to obtain assent/consent,
- Inability to tolerate 45 minutes in an MRI scanner,
- Contraindication to MRI (e.g., MRI incompatible implant or support device),
- Previous (remote) diagnosis or treatment of inflammatory bowel disease or other intestinal disease,
- History of intra-abdominal surgery, including surgery on the intestine,
- 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
- Inability to obtain assent/consent,
- Inability to tolerate 45 minutes in an MRI scanner,
- Contraindication to MRI (e.g., MRI incompatible implant or support device),
- Previous (remote) diagnosis or treatment of inflammatory bowel disease,
- 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),
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340519
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Jonathan R Dillman, MD, MSc | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT03340519 |
Other Study ID Numbers: |
CIN_EarlyMRCrohns |
First Posted: | November 13, 2017 Key Record Dates |
Last Update Posted: | February 11, 2022 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Only de-identified data will be shared |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Crohn MRI |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |