Value of Whole-body SPECT-CT CzT-based Camera (VERITON-CT) in the Assessment of Chronic Inflammatory Rheumatism With Axial Involvement

NCT ID: NCT06198361

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-02-01

Brief Summary

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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.

Nevertheless, spondyloarthritis is now the second most common chronic inflammatory rheumatic disease, affecting 0.43% of the french population.

The 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

MRI of the sacroiliac joints and thoracolumbar spine were used as a gold standard.

Detailed Description

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The present study was conducted by the Department of Rheumatology and Nuclear Medicine of the University Hospital Centre of Nancy (France).

An 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.

The 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).

The data collected was entered into an Excel spreadsheet protected by a security code.

For 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.

The investigators assessed the diagnostic performance of VERITON-CT (sensitivity, specificity), using MRI of the sacroiliac joints and thoracolumbar spine as the gold standard.

Conditions

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Spondyloarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Hospitalised patients (hospitalisation sector or day hospital)
* Patients who underwent SPECT-CT CzT-based camera for polyarthralgia or spinal pain between November 2021 and February 2023
* Patients who underwent axial MRI
* Initial suspicion of chronic inflammatory rheumatism

Exclusion Criteria

* Patients who did not give their consent
* Patients with extravasation of contrast agent at the injection site
* Patients with a missing phase on SPECT-CT (Blood-Pool phase or Delayed phase)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Chary-Valckenaere

Head of Rhumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline MORIZOT, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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Nancy University Hospital

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 24351517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27050638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28976332 (View on PubMed)

Other Identifiers

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2023PI091

Identifier Type: -

Identifier Source: org_study_id

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