Value of Whole-body SPECT-CT CzT-based Camera (VERITON-CT) in the Assessment of Chronic Inflammatory Rheumatism With Axial Involvement (ASOCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- SI MRI (binary)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
SI MRI (binary)
时间窗: 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
MRI SPARCC (Spondyloarthritis Research Consortium of Canada) Score
时间窗: 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
SI D phase (binary)
时间窗: November 1, 2021 to February 1, 2023
Positives sacroiliac joints data in VERITON-CT (Delayed phase) : binary value
SI SUV (Standardized Uptake Values) BP phase
时间窗: November 1, 2021 to February 1, 2023
Sum of the SUVs of the sacroiliac joints measured on VERITON-CT (Blood-Pool Phase) : quantitative value
Thoracolumbar SUV (Standardized Uptake Values) BP phase
时间窗: November 1, 2021 to February 1, 2023
Sum of the SUVs of the thoracolumbar spine measured on VERITON-CT (Blood-Pool Phase) : quantitative value
Thoracolumbar SUV D phase
时间窗: November 1, 2021 to February 1, 2023
Sum of the SUVs of the thoracolumbar spine measured on VERITON-CT (Delayed Phase) : quantitative value
Thoracolumbar MRI (binary)
时间窗: November 1, 2021 to February 1, 2023
Positives MRI of the thoracolumbar spine, ≥3 inflammatory discovertebral corners : binary value
Thoracolumbar D phase (binary)
时间窗: November 1, 2021 to February 1, 2023
Positives thoracolumbar spine data in VERITON-CT (Delayed phase) : binary value
SI BP phase (binary)
时间窗: November 1, 2021 to February 1, 2023
Positives sacroiliac joints data in VERITON-CT (Blood-Pool phase) : binary value
SI SUV D phase
时间窗: November 1, 2021 to February 1, 2023
Sum of the SUVs of the sacroiliac joints measured on VERITON-CT (Delayed Phase) : quantitative value
Thoracolumbar BP phase (binary)
时间窗: November 1, 2021 to February 1, 2023
Positives thoracolumbar spine data in VERITON-CT (Blood-Pool phase) : binary value
次要结局
未报告次要终点
研究者
Isabelle Chary-Valckenaere
Head of Rhumatology
Central Hospital, Nancy, France