ClinicalTrials.gg
Status unknownNCT05655533Updated Dec 19, 2022

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

An observational study in Spondyloarthropathy and Sacroilitis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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)

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)

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Conditions studied

  • Spondyloarthropathy and Sacroilitis

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In context

Spondylarthropathies

68 studies on the registry are indexed under Spondylarthropathies; 10 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 27 observational studies indexed under Spondylarthropathies.

Browse Spondylarthropathies studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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.

Inclusion criteria

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

Exclusion criteria

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 to MRI as claustrophobia, pacemaker.
Terms in these criteria, in plain language(1)

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.

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.

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

Interventions

  • Diagnostic testMagnetic 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

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 28110981 ↗
  • Chan 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 25293872 ↗
  • Zink 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 10743798 ↗
  • Ward MM. Health-related quality of life in ankylosing spondylitis: a survey of 175 patients. Arthritis Care Res. 1999 Aug;12(4):247-55. PubMed 10689989 ↗
  • Chan 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 30086145 ↗
  • Lambert 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 26768408 ↗
  • 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. PubMed 15082484 ↗
  • 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. PubMed 18806131 ↗
  • 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. PubMed 23813394 ↗
  • 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. PubMed 21311884 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2022; primary completion for May 2024, 17 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2022
First posted
Dec 19, 2022
StartEst.
Dec 10, 2022
Primary completionEst.
May 10, 2024
CompletionEst.
Oct 10, 2024
Last update
Dec 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05655533
Lead sponsor
Assiut University
Responsible party
Lamia a Arafat (Resident Physician, Assiut University) — Principal investigator
First posted
Dec 19, 2022
Start date
Dec 10, 2022 (estimated)
Primary completion
May 10, 2024 (estimated)
Completion
Oct 10, 2024 (estimated)
Last update
Dec 19, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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