Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

Study Purpose

This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Evidence of sacroiliitis on earlier standard of care MRE between 2014 and 2018.

- Confirmed diagnosis of Crohn's Disease.

- Known HLA-B27 status at time of enrollment and most recent clinical ESR and CRP results from chart (from day of visit or within past 4 weeks of study visit) - Adults >18 years of age.

Exclusion Criteria:

- History of other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout).

- Contraindication to MRI.

- History of malignancy <5 years in remission, (except for non-melanomatous skin cancer).

- Inability to comply with study protocol.

- Critically ill patients.

- Pregnant patients.

- Non-English speaking patients (as the questionnaires used in this study are not validated in other languages)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05203926
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Fardina Malik, MD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sacroiliitis

Additional Details

When axial spondyloarthritis (SpA) occurs in Crohn's disease (CD) is an important clinical and research question that has not been fully answered. Magnetic resonance enterography (MRE), routinely obtained in Crohn's disease (CD) patients, can be utilized to assess sacroiliac joints (SIJ); currently published literature shows that it could be a valuable tool to detect active inflammation of sacroiliitis in CD patients. Only a small fraction of CD patients with MRE evidence of sacroiliitis is referred to rheumatologists for further evaluation. The proposed project aims to further define MRE features of sacroiliitis in CD by recalling subjects who had prior positive findings and assess the natural history and outcome of these cases by standard magnetic resonance imaging (MRI) of sacroiliac joints and SIJ X-ray. 37 CD subjects who were already found to have sacroiliitis in the previous MRE study will be recalled. Subjects will undergo standard MRI of SIJ, plain X-ray of SIJ and the rheumatologist will obtain detailed history and examine patients for evaluation of possible axial SpA. Other details pertaining to CD, CD therapy and activity, will also be obtained to help clarify a correlation between CD and axial SpA. This pilot study will allow better characterization of imaging features of sacroiliitis on MRE, provide useful information on clinical significance of these lesions in CD patients, and potentially establish MRE as a screening tool for early detection of sacroiliitis in CD patients.

Arms & Interventions

Arms

Experimental: Crohn's disease (CD) subjects

These subjects will then undergo T1 and STIR sequence MRI of SI joints (pelvis MRI) as well as SIJ plain X-ray for assessment of radiographic sacroiliitis.

Interventions

Procedure: - MRI scan

Subjects will undergo T1 and STIR sequence MRI of sacroiliac joints (SIJ ) (pelvis MRI) as well as SIJ plain X-ray for assessment of radiographic sacroiliitis. The study will utilize 3 Tesla with phased array coil to maximize signal to noise ratio for image quality. This is a single procedure, which takes about 60 minutes. 1 radiologists, blinded to all clinical information, will evaluate for presence of acute and structural lesions. Images will be scored for presence or absence of acute and/or structural lesions in a global manner.

Contact a Trial Team

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NYU Langone Health, New York, New York

Status

Address

NYU Langone Health

New York, New York, 10016

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