Crohn DiseaseNCT03340519
Early MRI Prediction of Crohns
An observational study of Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 11 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- MR Imaging
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 18 Dec 2024
- 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 11 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy Control Group General population Newly Diagnosed Crohns Group Cincinnati Children's Inflammatory Bowel Disease Clinic
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease
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).
Read the detailed description
The investigators plan to evaluate novel MRI techniques to measure: 1) mesenteric/intestinal blood flow using phase-contrast cine MRI, 2) intestinal motility (peristalsis) using dynamic cine MRI, and 3) bowel wall perfusion and molecular water diffusion. Precise objective measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per minute) are not currently used in the clinical care of CD patients, while diffusion-weighted imaging is typically used in a qualitative manner. None of these techniques have been evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal healing in pediatric or adult CD.
- Conditions
- Crohn Disease
- Being tested
- MR Imaging
- Keywords
- Crohn, MRI
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR ImagingDevice
Novel MR imaging will be performed to provide bowel anatomic and functional data
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy Controls will undergo MR imaging to optimize MR techniques for bowel assessment and to acquire normative data Receives: Device: MR Imaging | |
| 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 Receives: Device: MR Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of therapeutic response in patients with Crohns disease
Assess novel MRI techniques for ability to predict early response to infliximab therapy in 20 newly diagnosed small bowel CD patients.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start17 Dec 2018
- Primary completion25 Oct 2021
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Crohn 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan R Dillman, MD, MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340519
- Sponsor's protocol ID
- CIN_EarlyMRCrohns
- Status last verified
- Feb 2025
- First submitted
- 9 Nov 2017
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only de-identified data will be shared
Publications
Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.
PubMed 19861953Aggarwal D, Limdi JK. Anti-TNF therapy is associated with a reduction in radiation exposure in patients with Crohn's disease. Eur J Gastroenterol Hepatol. 2015 Jan;27(1):13-9. doi: 10.1097/MEG.0000000000000222.
PubMed 25341058Church PC, Guan J, Walters TD, Frost K, Assa A, Muise AM, Griffiths AM. Infliximab maintains durable response and facilitates catch-up growth in luminal pediatric Crohn's disease. Inflamm Bowel Dis. 2014 Jul;20(7):1177-86. doi: 10.1097/MIB.0000000000000083.
PubMed 24865777Hyams JS, Lerer T, Griffiths A, Pfefferkorn M, Kugathasan S, Evans J, Otley A, Carvalho R, Mack D, Bousvaros A, Rosh J, Mamula P, Kay M, Crandall W, Oliva-Hemker M, Keljo D, LeLeiko N, Markowitz J; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Inflamm Bowel Dis. 2009 Jun;15(6):816-22. doi: 10.1002/ibd.20845.
PubMed 19107783Kane SV, Jaganathan S, Bedenbaugh AV, Palmer L, Schwartz DA. Anti-tumor necrosis factor agents reduce corticosteroid use compared with azathioprine in patients with Crohn's disease. Curr Med Res Opin. 2014 Sep;30(9):1821-6. doi: 10.1185/03007995.2014.928273. Epub 2014 Jun 2.
PubMed 24884302Mandel MD, Miheller P, Mullner K, Golovics PA, Lakatos PL. Have biologics changed the natural history of Crohn's disease? Dig Dis. 2014;32(4):351-9. doi: 10.1159/000358135. Epub 2014 Jun 23.
PubMed 24969279Viola F, Civitelli F, Di Nardo G, Barbato MB, Borrelli O, Oliva S, Conte F, Cucchiara S. Efficacy of adalimumab in moderate-to-severe pediatric Crohn's disease. Am J Gastroenterol. 2009 Oct;104(10):2566-71. doi: 10.1038/ajg.2009.372. Epub 2009 Jun 23.
PubMed 19550415Walters TD, Kim MO, Denson LA, Griffiths AM, Dubinsky M, Markowitz J, Baldassano R, Crandall W, Rosh J, Pfefferkorn M, Otley A, Heyman MB, LeLeiko N, Baker S, Guthery SL, Evans J, Ziring D, Kellermayer R, Stephens M, Mack D, Oliva-Hemker M, Patel AS, Kirschner B, Moulton D, Cohen S, Kim S, Liu C, Essers J, Kugathasan S, Hyams JS; PRO-KIIDS Research Group. Increased effectiveness of early therapy with anti-tumor necrosis factor-alpha vs an immunomodulator in children with Crohn's disease. Gastroenterology. 2014 Feb;146(2):383-91. doi: 10.1053/j.gastro.2013.10.027. Epub 2013 Oct 23.
PubMed 24162032Dillman JR, Adler J, Zimmermann EM, Strouse PJ. CT enterography of pediatric Crohn disease. Pediatr Radiol. 2010 Jan;40(1):97-105. doi: 10.1007/s00247-009-1465-5. Epub 2009 Nov 20.
PubMed 19936733Mollard BJ, Smith EA, Dillman JR. Pediatric MR enterography: technique and approach to interpretation-how we do it. Radiology. 2015 Jan;274(1):29-43. doi: 10.1148/radiol.14122449.
PubMed 25531478Brenner DJ. Should computed tomography be the modality of choice for imaging Crohn's disease in children? The radiation risk perspective. Gut. 2008 Nov;57(11):1489-90. doi: 10.1136/gut.2008.156265. No abstract available.
PubMed 18941001Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PubMed 18046031McDonald RJ, McDonald JS, Kallmes DF, Jentoft ME, Murray DL, Thielen KR, Williamson EE, Eckel LJ. Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging. Radiology. 2015 Jun;275(3):772-82. doi: 10.1148/radiol.15150025. Epub 2015 Mar 5.
PubMed 25742194Ramalho J, Castillo M, AlObaidy M, Nunes RH, Ramalho M, Dale BM, Semelka RC. High Signal Intensity in Globus Pallidus and Dentate Nucleus on Unenhanced T1-weighted MR Images: Evaluation of Two Linear Gadolinium-based Contrast Agents. Radiology. 2015 Sep;276(3):836-44. doi: 10.1148/radiol.2015150872. Epub 2015 Jun 16.
PubMed 26079490Bouguen G, Levesque BG, Feagan BG, Kavanaugh A, Peyrin-Biroulet L, Colombel JF, Hanauer SB, Sandborn WJ. Treat to target: a proposed new paradigm for the management of Crohn's disease. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1042-50.e2. doi: 10.1016/j.cgh.2013.09.006. Epub 2013 Sep 10.
PubMed 24036054
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease
- ClinicalTrials.gov ID
- NCT03340519
- Acronym / sponsor ID
- CIN_EarlyMRCrohns
- Conditions
- Crohn Disease
- Keywords
- Crohn, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 13 Nov 2017 (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 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).
Detailed description
The investigators plan to evaluate novel MRI techniques to measure: 1) mesenteric/intestinal blood flow using phase-contrast cine MRI, 2) intestinal motility (peristalsis) using dynamic cine MRI, and 3) bowel wall perfusion and molecular water diffusion. Precise objective measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per minute) are not currently used in the clinical care of CD patients, while diffusion-weighted imaging is typically used in a qualitative manner. None of these techniques have been evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal healing in pediatric or adult CD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Device: MR ImagingHealthy Controls will undergo MR imaging to optimize MR techniques for bowel assessment and to acquire normative data |
| Newly Diagnosed Crohns Patients | – | Device: MR ImagingMR 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 |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy Control Group General population Newly Diagnosed Crohns Group Cincinnati Children's Inflammatory Bowel Disease Clinic
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
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 |
|---|---|---|
| MR ImagingNovel MR imaging will be performed to provide bowel anatomic and functional data | Device | Healthy Controls, Newly Diagnosed Crohns Patients |
Primary outcome
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.
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 13 Feb 2025.
- Background: PubMed 19861953Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.
- Background: PubMed 25341058Aggarwal D, Limdi JK. Anti-TNF therapy is associated with a reduction in radiation exposure in patients with Crohn's disease. Eur J Gastroenterol Hepatol. 2015 Jan;27(1):13-9. doi: 10.1097/MEG.0000000000000222.
- Background: PubMed 24865777Church PC, Guan J, Walters TD, Frost K, Assa A, Muise AM, Griffiths AM. Infliximab maintains durable response and facilitates catch-up growth in luminal pediatric Crohn's disease. Inflamm Bowel Dis. 2014 Jul;20(7):1177-86. doi: 10.1097/MIB.0000000000000083.
- Background: PubMed 19107783Hyams JS, Lerer T, Griffiths A, Pfefferkorn M, Kugathasan S, Evans J, Otley A, Carvalho R, Mack D, Bousvaros A, Rosh J, Mamula P, Kay M, Crandall W, Oliva-Hemker M, Keljo D, LeLeiko N, Markowitz J; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Inflamm Bowel Dis. 2009 Jun;15(6):816-22. doi: 10.1002/ibd.20845.
- Background: PubMed 24884302Kane SV, Jaganathan S, Bedenbaugh AV, Palmer L, Schwartz DA. Anti-tumor necrosis factor agents reduce corticosteroid use compared with azathioprine in patients with Crohn's disease. Curr Med Res Opin. 2014 Sep;30(9):1821-6. doi: 10.1185/03007995.2014.928273. Epub 2014 Jun 2.
- Background: PubMed 24969279Mandel MD, Miheller P, Mullner K, Golovics PA, Lakatos PL. Have biologics changed the natural history of Crohn's disease? Dig Dis. 2014;32(4):351-9. doi: 10.1159/000358135. Epub 2014 Jun 23.
- Background: PubMed 19550415Viola F, Civitelli F, Di Nardo G, Barbato MB, Borrelli O, Oliva S, Conte F, Cucchiara S. Efficacy of adalimumab in moderate-to-severe pediatric Crohn's disease. Am J Gastroenterol. 2009 Oct;104(10):2566-71. doi: 10.1038/ajg.2009.372. Epub 2009 Jun 23.
- Background: PubMed 24162032Walters TD, Kim MO, Denson LA, Griffiths AM, Dubinsky M, Markowitz J, Baldassano R, Crandall W, Rosh J, Pfefferkorn M, Otley A, Heyman MB, LeLeiko N, Baker S, Guthery SL, Evans J, Ziring D, Kellermayer R, Stephens M, Mack D, Oliva-Hemker M, Patel AS, Kirschner B, Moulton D, Cohen S, Kim S, Liu C, Essers J, Kugathasan S, Hyams JS; PRO-KIIDS Research Group. Increased effectiveness of early therapy with anti-tumor necrosis factor-alpha vs an immunomodulator in children with Crohn's disease. Gastroenterology. 2014 Feb;146(2):383-91. doi: 10.1053/j.gastro.2013.10.027. Epub 2013 Oct 23.
- Background: PubMed 19936733Dillman JR, Adler J, Zimmermann EM, Strouse PJ. CT enterography of pediatric Crohn disease. Pediatr Radiol. 2010 Jan;40(1):97-105. doi: 10.1007/s00247-009-1465-5. Epub 2009 Nov 20.
- Background: PubMed 25531478Mollard BJ, Smith EA, Dillman JR. Pediatric MR enterography: technique and approach to interpretation-how we do it. Radiology. 2015 Jan;274(1):29-43. doi: 10.1148/radiol.14122449.
- Background: PubMed 18941001Brenner DJ. Should computed tomography be the modality of choice for imaging Crohn's disease in children? The radiation risk perspective. Gut. 2008 Nov;57(11):1489-90. doi: 10.1136/gut.2008.156265. No abstract available.
- Background: PubMed 18046031Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
- Individual participant dataSharing planned: No. Only de-identified data will be shared
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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.
Jonathan R Dillman, MD, MSc principal investigator
Children's Hospital Medical Center, Cincinnati
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 Children's Hospital Medical Center, Cincinnati 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 8 inclusion and 15 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 13 Feb 2025. 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?
Prediction of therapeutic response in patients with Crohns disease (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03340519, which also lists 33 linked publications.
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 13 Feb 2025.