An interventional study of MRI scan in Sacroiliitis, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
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.
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.
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's enrollment of 27 is below the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.
Time frame: 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.
Time frame: Intervention Visit 1 (Day 1)
Measurement of Ankylosing Spondylitis Disease Activity
ASDAS- Ankylosing Spondylitis Disease Activity Score will assesses patient-perceived symptoms and current disease activity through serum markers. The higher the score the higher the disease activity.
Time frame: Intervention Visit 1 (Day 1)
Measurement of Bath Ankylosing Spondylitis Disease Activity Index
BASDAI- Bath Ankylosing Spondylitis Disease Activity Index assesses Ankylosing Spondylitis Disease activity and current symptoms. The BASDAI sum score is calculated by the sum of questions 1-4 plus mean of questions 5 and 6, the total then divided by 5. The sum score ranges from 0 to 10, higher values indicate more active disease.
Time frame: Intervention Visit 1 (Day 1)
Measurement of Bath Ankylosing Spondylitis Functional Index
BASFI- Bath Ankylosing Spondylitis Functional Index assesses functional limitation in patients with Ankylosing Spondylitis. The patient rates his/her ability to perform tasks (BASFI) by marking a vertical line on a 100 mm horizontal line. It consists of ten tasks lines to assess the degree of difficulty of performing each task. The total BASFI score is calculated by adding all ten scores and dividing by 10.
Time frame: Intervention Visit 1 (Day 1)
Measurement of HBI- Harvey-Bradshaw Index
HBI- Harvey-Bradshaw Index measures clinical activity of Crohn's Disease. The categorical HBI score was also used as an independent variable in all analyses. Specifically, HBI \< 5 was defined as clinical remission, HBI between 5 and 7 as mild disease, HBI between 8 and 16 as moderate disease, and HBI \> 16 as severe disease.
Time frame: Intervention Visit 1 (Day 1)
Measurement of CDAI- Crohn's Disease Activity Index
CDAI- Crohn's Disease Activity Index determines current severity of Crohn's Disease. CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease.
Time frame: Intervention Visit 1 (Day 1)
Plan to share: No — Data collected from this study include anthropomorphic and blood draw data that will be uploaded to the participants' EHR and questionnaire data that will only be used for study-related purposes
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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