Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT05655533
Status:
UNKNOWN
Last Update Posted:
2022-12-19
First Post:
2022-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025242', 'term': 'Spondylarthropathies'}], 'ancestors': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'value of diffusion weighted MRI in evaluation of sacroiliitis in newly diagnosed patients of spondyloarthropathy.', 'timeFrame': 'one year', 'description': 'Diagnostic value of Diffusion weighted MRI of Sacroiliac joint compared to Conventional sequence MRI of sacroiliac joint for the diagnosis of sacroiliitis.'}], 'secondaryOutcomes': [{'measure': 'Early diagnosis of spondyloarthropathy', 'timeFrame': 'one year', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spondyloarthropathy and Sacroilitis']}, 'referencesModule': {'references': [{'pmid': '28110981', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25293872', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10743798', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10689989', 'type': 'BACKGROUND', 'citation': 'Ward MM. Health-related quality of life in ankylosing spondylitis: a survey of 175 patients. Arthritis Care Res. 1999 Aug;12(4):247-55.'}, {'pmid': '30086145', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26768408', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15082484', 'type': 'BACKGROUND', '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.'}, {'pmid': '18806131', 'type': 'BACKGROUND', '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.'}, {'pmid': '23813394', 'type': 'BACKGROUND', '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.'}, {'pmid': '21311884', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Spondyloarthropathy encompasses a group of chronic immune-mediated rheumatic inflammatory diseases characterized by axial joint inflammation, peripheral arthritis, enthesitis, dactylitis and extra-articular features.\n\nAxial 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).\n\nThere\'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.\n\nSacroiliitis 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.\n\nDiffusion-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)', 'detailedDescription': '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\\].\n\nAxial 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).\n\nThere\'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.\n\nSacroiliitis 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who clinically suspected to have early spondyloarthropathy in acute stage, referred from rheumatologists or orthopedic clinicians.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients who are suspected clinically to have early spondyloarthropathy with acute sacroiliitis.\n\nExclusion Criteria:\n\n* Known patients with chronic spondyloarthropathy under medical treatment.\n* Patients with previous surgical operations and metallic screws fixation at pelvic region.\n* Patients refused the examination.\n* Patients with contraindication to MRI as claustrophobia, pacemaker.'}, 'identificationModule': {'nctId': 'NCT05655533', 'briefTitle': 'Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Added Value of Diffusion Weighted MRI in Evaluation of Sacroiliitis in Newly Diagnosed Patients of Spondyloarthropathy.', 'orgStudyIdInfo': {'id': '455457'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients who clinically suspected to have early spondyloarthropathy', 'description': 'Adult patients who clinically suspected to have early spondyloarthropathy in acute stage.\n\nAt least 4 of 5 criteria for inflammatory low back pain have to be fulfilled', 'interventionNames': ['Diagnostic Test: Magnetic resonance Imaging scanners of sacroiliac joints.']}], 'interventions': [{'name': 'Magnetic resonance Imaging scanners of sacroiliac joints.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo MR imaging examinations with a closed 1.5-Tesla Magnetic resonance Imaging scanners of sacroiliac joints.\n\nThe patients will be imaged in the supine position using a body phased-array coil.\n\nEvaluate 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', 'armGroupLabels': ['Adult patients who clinically suspected to have early spondyloarthropathy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Lamia a Arafat', 'investigatorAffiliation': 'Assiut University'}}}}