Clinical trial NCT05655533: Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.
Official title: Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spondyloarthropathy and Sacroilitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who clinically suspected to have early spondyloarthropathy in acute stage, referred from rheumatologists or orthopedic clinicians.

Brief summary: Spondyloarthropathy encompasses a group of chronic immune-mediated rheumatic inflammatory diseases characterized by axial joint inflammation, peripheral arthritis, enthesitis, dactylitis and extra-articular features.

Axial spondyloarthritis (SpA) has significant social and psychiatric impacts \[2, 3\] and affects quality-of-life (4-5).Early disease diagnosis is becoming more important as it will facilitate early therapeutic interventions (6).

There's no "gold standard" feature for diagnosing axSpA. It's diagnosed through a combination of patient history, clinical examination, laboratory findings a and imaging tests, such as X-ray and MRI.

Sacroiliitis is commonly the first manifestation and an important indicator of the diagnosis and classification of the the disease. (7) Radiographic sacroiliitis is a key criterion. However, sole reliance on radiographs is associated with significant diagnostic delay \[8\]. Magnetic Resonance Imaging (MRI) can detect axial inflammation before radiographic changes.

Diffusion-weighted imaging (DWI) offers a new approach to assess inflammation. Recently several studies have shown that DWI is an effective tool in early diagnosis of axSpA (14-16). Furthermore, the ADC value may serve as a quantitative biomarker of disease activity, allowing monitoring and guiding treatment. (17-18)

Detailed description: Spondyloarthropathy encompasses a group of chronic immune-mediated rheumatic inflammatory diseases characterized by axial joint inflammation, peripheral arthritis, enthesitis, dactylitis and extra-articular features such as psoriasis, uveitis, inflammatory bowel disease (crohns and ulcerative colitis) \[1\].

Axial spondyloarthritis (SpA) has significant social and psychiatric impacts \[2, 3\] and affects quality-of-life (4-5). Patients often experience prolonged delays in diagnosis. Early disease diagnosis is becoming more important as it will facilitate early therapeutic interventions (6).

There's no "gold standard" feature for diagnosing axSpA. It's diagnosed through a combination of patient history, clinical examination, laboratory findings as blood tests (both for HLA-B27 and for markers of inflammation, such as C-reactive protein), and imaging tests, such as X-ray and MRI.

Sacroiliitis is commonly the first manifestation and an important indicator of the diagnosis and classification of the the disease. (7) Radiographic sacroiliitis is a key criterion. However, sole reliance on radiographs is associated with significant diagnostic delay \[8\]. Magnetic Resonance Imaging (MRI) can detect axial inflammation before radiographic changes. (9) So with the development of Assessment of Spondyloarthritis International Society (ASAS) classification criteria for ax-SpA, MRI is increasingly being used to early diagnose and monitor disease activity. (10) Diffusion-weighted imaging (DWI) offers a new approach to assess inflammation. It is a functional MRI technique that can non-invasively asses the random movements of water molecules through the measurements of the ADC value. (11). Inflammation produces an increase in the apparent diffusion coefficient (ADC) of water molecules in affected tissues, probably owing to an increase in the ratio of extracellular to intracellular water. (12-13) Recently several studies have shown that DWI is an effective tool in early diagnosis of axSpA (14-16). Furthermore, the ADC value may serve as a quantitative biomarker of disease activity, allowing monitoring and guiding treatment. (17-18)

Eligibility criteria: Inclusion Criteria:

* All adult patients who are suspected clinically to have early spondyloarthropathy with acute sacroiliitis.

Exclusion Criteria:

* Known patients with chronic spondyloarthropathy under medical treatment.
* Patients with previous surgical operations and metallic screws fixation at pelvic region.
* Patients refused the examination.
* Patients with contraindication to MRI as claustrophobia, pacemaker.

Primary outcomes:
measure: value of diffusion weighted MRI in evaluation of sacroiliitis in newly diagnosed patients of spondyloarthropathy.
timeFrame: one year
Secondary outcomes:
measure: Early diagnosis of spondyloarthropathy
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
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citation: Rudwaleit M, van der Heijde D, Khan MA, Braun J, Sieper J. How to diagnose axial spondyloarthritis early. Ann Rheum Dis. 2004 May;63(5):535-43. doi: 10.1136/ard.2003.011247.
citation: Bozgeyik Z, Ozgocmen S, Kocakoc E. Role of diffusion-weighted MRI in the detection of early active sacroiliitis. AJR Am J Roentgenol. 2008 Oct;191(4):980-6. doi: 10.2214/AJR.07.3865.
citation: Carmona R, Harish S, Linda DD, Ioannidis G, Matsos M, Khalidi NA. MR imaging of the spine and sacroiliac joints for spondyloarthritis: influence on clinical diagnostic confidence and patient management. Radiology. 2013 Oct;269(1):208-15. doi: 10.1148/radiol.13121675. Epub 2013 Jun 27.
citation: Khoo MM, Tyler PA, Saifuddin A, Padhani AR. Diffusion-weighted imaging (DWI) in musculoskeletal MRI: a critical review. Skeletal Radiol. 2011 Jun;40(6):665-81. doi: 10.1007/s00256-011-1106-6. Epub 2011 Feb 12.