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Completed

NCT Number: NCT06198361

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

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.

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Sacroiliitis Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nancy University Hospital

Vandœuvre-lès-Nancy, 54500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. SI MRI (binary)

    Time frame: November 1, 2021 to February 1, 2023

    Positives MRI of the sacroiliac joints, according to the ASAS (Assessment of SpondyloArthritis international Society) criteria : binary value

  2. MRI SPARCC (Spondyloarthritis Research Consortium of Canada) Score

    Time frame: November 1, 2021 to February 1, 2023

    SPARCC scores of the sacroiliac joints and of the thoracolumbar spine in MRI : quantitative value.

    Thoraco-lumbar SPARCC score : from 0 to 108, higher scores means worst outcome SI SPARCC score : from 0 to 72, higher scores means worst outcome

  3. SI BP phase (binary)

    Time frame: November 1, 2021 to February 1, 2023

    Positives sacroiliac joints data in VERITON-CT (Blood-Pool phase) : binary value

  4. SI D phase (binary)

    Time frame: November 1, 2021 to February 1, 2023

    Positives sacroiliac joints data in VERITON-CT (Delayed phase) : binary value

  5. SI SUV (Standardized Uptake Values) BP phase

    Time frame: November 1, 2021 to February 1, 2023

    Sum of the SUVs of the sacroiliac joints measured on VERITON-CT (Blood-Pool Phase) : quantitative value

  6. Thoracolumbar SUV (Standardized Uptake Values) BP phase

    Time frame: November 1, 2021 to February 1, 2023

    Sum of the SUVs of the thoracolumbar spine measured on VERITON-CT (Blood-Pool Phase) : quantitative value

  7. SI SUV D phase

    Time frame: November 1, 2021 to February 1, 2023

    Sum of the SUVs of the sacroiliac joints measured on VERITON-CT (Delayed Phase) : quantitative value

  8. Thoracolumbar SUV D phase

    Time frame: November 1, 2021 to February 1, 2023

    Sum of the SUVs of the thoracolumbar spine measured on VERITON-CT (Delayed Phase) : quantitative value

  9. Thoracolumbar MRI (binary)

    Time frame: November 1, 2021 to February 1, 2023

    Positives MRI of the thoracolumbar spine, ≥3 inflammatory discovertebral corners : binary value

  10. Thoracolumbar BP phase (binary)

    Time frame: November 1, 2021 to February 1, 2023

    Positives thoracolumbar spine data in VERITON-CT (Blood-Pool phase) : binary value

  11. Thoracolumbar D phase (binary)

    Time frame: November 1, 2021 to February 1, 2023

    Positives thoracolumbar spine data in VERITON-CT (Delayed phase) : binary value

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ASOCE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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