Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.

December 9, 2022 updated by: Lamia a Arafat, Assiut University

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients who clinically suspected to have early spondyloarthropathy

Adult patients who clinically suspected to have early spondyloarthropathy in acute stage.

At least 4 of 5 criteria for inflammatory low back pain have to be fulfilled
Diagnostic test: Magnetic resonance Imaging scanners of sacroiliac joints.

Patients will undergo MR imaging examinations with a closed 1.5-Tesla Magnetic resonance Imaging scanners of sacroiliac joints.

The patients will be imaged in the supine position using a body phased-array coil.

Evaluate the added value of DWI in detection of acute sacroiliitis and whether ADC values can be helpful in detection and differentiation of active stage, so determine whether supplementation of DWI with quantitative ADC mapping to the routine MR examination is of great value as non-invasive tool or not

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
value of diffusion weighted MRI in evaluation of sacroiliitis in newly diagnosed patients of spondyloarthropathy.
Time Frame: one year
Diagnostic value of Diffusion weighted MRI of Sacroiliac joint compared to Conventional sequence MRI of sacroiliac joint for the diagnosis of sacroiliitis.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early diagnosis of spondyloarthropathy
Time Frame: one year
Early diagnosis of spondyloarthropathy by early detection of sacroiliitis in clinically suspected patients will facilitate early therapeutic interventions thus lead to dramatic improvements in the management of axial SpA by reducing symptoms and preserving functional status.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 10, 2022

Primary Completion (Anticipated)

May 10, 2024

Study Completion (Anticipated)

October 10, 2024

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 19, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 455457

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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