Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-31 @ 6:01 PM
Study NCT ID:
NCT06198361
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2023-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Value of Whole-body SPECT-CT CzT-based Camera (VERITON-CT) in the Assessment of Chronic Inflammatory Rheumatism With Axial Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D058566', 'term': 'Sacroiliitis'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2023-12-27', 'studyFirstSubmitQcDate': '2023-12-27', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SI MRI (binary)', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Positives MRI of the sacroiliac joints, according to the ASAS (Assessment of SpondyloArthritis international Society) criteria : binary value'}, {'measure': 'MRI SPARCC (Spondyloarthritis Research Consortium of Canada) Score', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'SPARCC scores of the sacroiliac joints and of the thoracolumbar spine in MRI : quantitative value.\n\nThoraco-lumbar SPARCC score : from 0 to 108, higher scores means worst outcome SI SPARCC score : from 0 to 72, higher scores means worst outcome'}, {'measure': 'SI BP phase (binary)', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Positives sacroiliac joints data in VERITON-CT (Blood-Pool phase) : binary value'}, {'measure': 'SI D phase (binary)', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Positives sacroiliac joints data in VERITON-CT (Delayed phase) : binary value'}, {'measure': 'SI SUV (Standardized Uptake Values) BP phase', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Sum of the SUVs of the sacroiliac joints measured on VERITON-CT (Blood-Pool Phase) : quantitative value'}, {'measure': 'Thoracolumbar SUV (Standardized Uptake Values) BP phase', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Sum of the SUVs of the thoracolumbar spine measured on VERITON-CT (Blood-Pool Phase) : quantitative value'}, {'measure': 'SI SUV D phase', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Sum of the SUVs of the sacroiliac joints measured on VERITON-CT (Delayed Phase) : quantitative value'}, {'measure': 'Thoracolumbar SUV D phase', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Sum of the SUVs of the thoracolumbar spine measured on VERITON-CT (Delayed Phase) : quantitative value'}, {'measure': 'Thoracolumbar MRI (binary)', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Positives MRI of the thoracolumbar spine, ≥3 inflammatory discovertebral corners : binary value'}, {'measure': 'Thoracolumbar BP phase (binary)', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Positives thoracolumbar spine data in VERITON-CT (Blood-Pool phase) : binary value'}, {'measure': 'Thoracolumbar D phase (binary)', 'timeFrame': 'November 1, 2021 to February 1, 2023', 'description': 'Positives thoracolumbar spine data in VERITON-CT (Delayed phase) : binary value'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spondyloarthritis', 'sacroiliitis', 'sacroiliac joints', 'VERITON-CT', 'SPECT-CT', 'thoracolumbar spine'], 'conditions': ['Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '24351517', 'type': 'BACKGROUND', 'citation': 'Costantino F, Talpin A, Said-Nahal R, Goldberg M, Henny J, Chiocchia G, Garchon HJ, Zins M, Breban M. Prevalence of spondyloarthritis in reference to HLA-B27 in the French population: results of the GAZEL cohort. Ann Rheum Dis. 2015 Apr;74(4):689-93. doi: 10.1136/annrheumdis-2013-204436. Epub 2013 Dec 18.'}, {'pmid': '27050638', 'type': 'BACKGROUND', 'citation': 'Pialat JB, Di Marco L, Feydy A, Peyron C, Porta B, Himpens PH, Ltaief-Boudrigua A, Aubry S. Sacroiliac joints imaging in axial spondyloarthritis. Diagn Interv Imaging. 2016 Jul-Aug;97(7-8):697-708. doi: 10.1016/j.diii.2016.02.013. Epub 2016 Mar 31.'}, {'pmid': '28976332', 'type': 'BACKGROUND', 'citation': 'Pipikos T, Kassimos D, Angelidis G, Koutsikos J. Bone Single Photon Emission/Computed Tomography in the Detection of Sacroiliitis in Seronegative Spondyloarthritis: A Comparison with Magnetic Resonance Imaging. Mol Imaging Radionucl Ther. 2017 Oct 3;26(3):101-109. doi: 10.4274/mirt.50570.'}]}, 'descriptionModule': {'briefSummary': 'The diagnosis of chronic inflammatory rheumatism with axial involvement is not always easy, and is fraught with difficulties : radiological sacroiliitis is not an early sign of spondyloarthritis and the delay in detecting radiological signs contributes to the delay in diagnosis.\n\nNevertheless, spondyloarthritis is now the second most common chronic inflammatory rheumatic disease, affecting 0.43% of the french population.\n\nThe aim of this retrospective study is to evaluate the diagnostic performance of whole-body SPECT-CT CzT-based camera (VERITON-CT) in the assessment of chronic inflammatory rheumatism with axial involvement\n\nMRI of the sacroiliac joints and thoracolumbar spine were used as a gold standard.', 'detailedDescription': 'The present study was conducted by the Department of Rheumatology and Nuclear Medicine of the University Hospital Centre of Nancy (France).\n\nAn initial number of 51 hospitalised patients (35 females, 16 males) who underwent SPECT-CT CzT-based camera for polyarthralgia or spinal pain between November 2021 and February 2023 and initial suspicion of chronic inflammatory rheumatism were included in the study.\n\nThe investigators retrospectively reviewed the electronic medical records of the consecutive patients using medical softwares (DxCare or VNA Philips). The investigators collected demographic data (age, gender), clinical data (anamnesis, pain level (EVA) and location, standardized clinical activity scores like Ankylosing Spondylitis Disease Activity Score (ASDAS), Widespread Pain Index (WPI), symptom severity scale (SSS)), biological data (protein chain reaction in milligrams per litre), and medical imaging data (X-rays, MRI and CT scans).\n\nThe data collected was entered into an Excel spreadsheet protected by a security code.\n\nFor medical imaging data, the investigators performed a reading of the sacroiliac and thoracolumbar spine medical imaging under the supervision of an experienced rheumatologist specialising in chronic inflammatory rheumatism.\n\nThe investigators assessed the diagnostic performance of VERITON-CT (sensitivity, specificity), using MRI of the sacroiliac joints and thoracolumbar spine as the gold standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '78 patients with SPECT-CT\n\nAmong them : 51 patients with axial MRI (spine n=42 and/or sacroiliac joints n=47) :\n\n* 1 excluded for extravasation of contrast agent at the injection site\n* 1 excluded for "blood- pool phase" SPECT missing\n\nFor a total of n = 47 patients (sacroiliac MRI); 25 classified as spondyloarthritis : axial spondyloarthritis, ankylosis spondylitis, psoriatic arthritis, SAPHO syndrome ; And 22 non-spondyloarthritis : Fibromyalgia, osteoarthritis, rheumatoid arthritis, Bertolotti syndrom, scoliosis, familial Mediterranean fever…\n\nFor a total of n = 42 patients (thoracolumbar MRI); 22 patients in spondyloarthritis group (15 spondyloarthritis, 4 psoriatic arthritis and 3 SAPHO syndrome) and 20 in non-spondyloarthritis group (1 rheumatoid arthritis, 2 fibromyalgia, 13 osteoarthritis, 1 familial Mediterranean fever, 2 arthralgia in IBD and 1 arthralgia in cystic fibrosis).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalised patients (hospitalisation sector or day hospital)\n* Patients who underwent SPECT-CT CzT-based camera for polyarthralgia or spinal pain between November 2021 and February 2023\n* Patients who underwent axial MRI\n* Initial suspicion of chronic inflammatory rheumatism\n\nExclusion Criteria:\n\n* Patients who did not give their consent\n* Patients with extravasation of contrast agent at the injection site\n* Patients with a missing phase on SPECT-CT (Blood-Pool phase or Delayed phase)'}, 'identificationModule': {'nctId': 'NCT06198361', 'acronym': 'ASOCE', 'briefTitle': 'Value of Whole-body SPECT-CT CzT-based Camera (VERITON-CT) in the Assessment of Chronic Inflammatory Rheumatism With Axial Involvement', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Value of Whole-body SPECT-CT CzT-based Camera (VERITON-CT) in the Assessment of Chronic Inflammatory Rheumatism With Axial Involvement (ASOCE)', 'orgStudyIdInfo': {'id': '2023PI091'}}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Nancy University Hospital', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Caroline MORIZOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Rhumatology', 'investigatorFullName': 'Isabelle Chary-Valckenaere', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}