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

NCT05203926 | Completed DMC

• 1 other identifier: 21-00955
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sacroiliitis

Outcome Measures

Primary Outcomes (2)

• Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

  The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.

  Intervention Visit 1 (Day 1)

• Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

  The X-ray exams will establish significance of sacroiliitis features/lesions seen on MRE.

  Intervention Visit 1 (Day 1)

Secondary Outcomes (5)

• Measurement of Ankylosing Spondylitis Disease Activity

  Intervention Visit 1 (Day 1)

• Measurement of Bath Ankylosing Spondylitis Disease Activity Index

  Intervention Visit 1 (Day 1)

• Measurement of Bath Ankylosing Spondylitis Functional Index

  Intervention Visit 1 (Day 1)

• Measurement of HBI- Harvey-Bradshaw Index

  Intervention Visit 1 (Day 1)

• Measurement of CDAI- Crohn's Disease Activity Index

  Intervention Visit 1 (Day 1)

Study Arms (1)

Crohn's disease (CD) subjects

EXPERIMENTAL

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.

Procedure: MRI scan

Interventions

MRI scan PROCEDURE

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.

Crohn's disease (CD) subjects

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• Spondyloarthritis Research and Treatment Network: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sacroiliitis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Fardina Malik, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 24, 2022
• Study Start: March 14, 2022
• Primary Completion: November 4, 2023
• Study Completion: November 4, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)