Spondyloarthropathy and SacroilitisNCT05655533
Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.
An observational study of Spondyloarthropathy and Sacroilitis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthropathy and Sacroilitis
- What is being tested?
- Magnetic resonance Imaging scanners of sacroiliac joints.
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2022to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients who clinically suspected to have early spondyloarthropathy in acute stage, referred from rheumatologists or orthopedic clinicians.
Who may be able to join
- All adult patients who are suspected clinically to have early spondyloarthropathy with acute sacroiliitis.
Who cannot join
- 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.
About this study
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).
Read more
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)
Read the 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)
- Conditions
- Spondyloarthropathy and Sacroilitis
- Being tested
- Magnetic resonance Imaging scanners of sacroiliac joints.
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance Imaging scanners of sacroiliac joints.Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Magnetic resonance Imaging scanners of sacroiliac joints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of diffusion weighted MRI in evaluation of sacroiliitis in newly diagnosed patients of spondyloarthropathy.
Diagnostic value of Diffusion weighted MRI of Sacroiliac joint compared to Conventional sequence MRI of sacroiliac joint for the diagnosis of sacroiliitis.
Measured: one year
Secondary outcomes (1)
Early diagnosis of spondyloarthropathy
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start10 Dec 2022 (estimated)
- Primary completion10 May 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spondyloarthropathy and SacroilitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia a Arafat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655533
- Sponsor's protocol ID
- 455457
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. 2017 Jul 1;390(10089):73-84. doi: 10.1016/S0140-6736(16)31591-4. Epub 2017 Jan 20.
PubMed 28110981Chan CYY, Tsang HHL, Lau CS, Chung HY. Prevalence of depressive and anxiety disorders and validation of the Hospital Anxiety and Depression Scale as a screening tool in axial spondyloarthritis patients. Int J Rheum Dis. 2017 Mar;20(3):317-325. doi: 10.1111/1756-185X.12456. Epub 2014 Oct 7.
PubMed 25293872Zink A, Braun J, Listing J, Wollenhaupt J. Disability and handicap in rheumatoid arthritis and ankylosing spondylitis--results from the German rheumatological database. German Collaborative Arthritis Centers. J Rheumatol. 2000 Mar;27(3):613-22.
PubMed 10743798Ward MM. Health-related quality of life in ankylosing spondylitis: a survey of 175 patients. Arthritis Care Res. 1999 Aug;12(4):247-55.
PubMed 10689989Chan CWS, Tsang HHL, Li PH, Lee KH, Lau CS, Wong PYS, Chung HY. Diffusion-weighted imaging versus short tau inversion recovery sequence: Usefulness in detection of active sacroiliitis and early diagnosis of axial spondyloarthritis. PLoS One. 2018 Aug 7;13(8):e0201040. doi: 10.1371/journal.pone.0201040. eCollection 2018.
PubMed 30086145Lambert RG, Bakker PA, van der Heijde D, Weber U, Rudwaleit M, Hermann KG, Sieper J, Baraliakos X, Bennett A, Braun J, Burgos-Vargas R, Dougados M, Pedersen SJ, Jurik AG, Maksymowych WP, Marzo-Ortega H, Ostergaard M, Poddubnyy D, Reijnierse M, van den Bosch F, van der Horst-Bruinsma I, Landewe R. Defining active sacroiliitis on MRI for classification of axial spondyloarthritis: update by the ASAS MRI working group. Ann Rheum Dis. 2016 Nov;75(11):1958-1963. doi: 10.1136/annrheumdis-2015-208642. Epub 2016 Jan 14.
PubMed 26768408Rudwaleit 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.
PubMed 15082484Bozgeyik 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.
PubMed 18806131Carmona 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.
PubMed 23813394Khoo 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.
PubMed 21311884
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.
- ClinicalTrials.gov ID
- NCT05655533
- Acronym / sponsor ID
- 455457
- Conditions
- Spondyloarthropathy and Sacroilitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (estimated)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients who clinically suspected to have early spondyloarthropathy | – | Diagnostic Test: Magnetic resonance Imaging scanners of sacroiliac joints.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who clinically suspected to have early spondyloarthropathy in acute stage, referred from rheumatologists or orthopedic clinicians.
Key inclusion criteria (1 listed)
- All adult patients who are suspected clinically to have early spondyloarthropathy with acute sacroiliitis.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Adult patients who clinically suspected to have early spondyloarthropathy |
Primary outcome
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.
1 secondary outcome
Early diagnosis of spondyloarthropathy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Background: PubMed 28110981Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. 2017 Jul 1;390(10089):73-84. doi: 10.1016/S0140-6736(16)31591-4. Epub 2017 Jan 20.
- Background: PubMed 25293872Chan CYY, Tsang HHL, Lau CS, Chung HY. Prevalence of depressive and anxiety disorders and validation of the Hospital Anxiety and Depression Scale as a screening tool in axial spondyloarthritis patients. Int J Rheum Dis. 2017 Mar;20(3):317-325. doi: 10.1111/1756-185X.12456. Epub 2014 Oct 7.
- Background: PubMed 10743798Zink A, Braun J, Listing J, Wollenhaupt J. Disability and handicap in rheumatoid arthritis and ankylosing spondylitis--results from the German rheumatological database. German Collaborative Arthritis Centers. J Rheumatol. 2000 Mar;27(3):613-22.
- Background: PubMed 10689989Ward MM. Health-related quality of life in ankylosing spondylitis: a survey of 175 patients. Arthritis Care Res. 1999 Aug;12(4):247-55.
- Background: PubMed 30086145Chan CWS, Tsang HHL, Li PH, Lee KH, Lau CS, Wong PYS, Chung HY. Diffusion-weighted imaging versus short tau inversion recovery sequence: Usefulness in detection of active sacroiliitis and early diagnosis of axial spondyloarthritis. PLoS One. 2018 Aug 7;13(8):e0201040. doi: 10.1371/journal.pone.0201040. eCollection 2018.
- Background: PubMed 26768408Lambert RG, Bakker PA, van der Heijde D, Weber U, Rudwaleit M, Hermann KG, Sieper J, Baraliakos X, Bennett A, Braun J, Burgos-Vargas R, Dougados M, Pedersen SJ, Jurik AG, Maksymowych WP, Marzo-Ortega H, Ostergaard M, Poddubnyy D, Reijnierse M, van den Bosch F, van der Horst-Bruinsma I, Landewe R. Defining active sacroiliitis on MRI for classification of axial spondyloarthritis: update by the ASAS MRI working group. Ann Rheum Dis. 2016 Nov;75(11):1958-1963. doi: 10.1136/annrheumdis-2015-208642. Epub 2016 Jan 14.
- Background: PubMed 15082484Rudwaleit 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.
- Background: PubMed 18806131Bozgeyik 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.
- Background: PubMed 23813394Carmona 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.
- Background: PubMed 21311884Khoo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthropathy and Sacroilitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of diffusion weighted MRI in evaluation of sacroiliitis in newly diagnosed patients of spondyloarthropathy. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655533, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.