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

NCT06198361 | Completed

• 1 other identifier: 2023PI091
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spondyloarthritis

Keywords

spondyloarthritis; sacroiliitis; sacroiliac joints; VERITON-CT; SPECT-CT; thoracolumbar spine

Outcome Measures

Primary Outcomes (11)

• SI MRI (binary)

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

  November 1, 2021 to February 1, 2023

• MRI SPARCC (Spondyloarthritis Research Consortium of Canada) Score

  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

  November 1, 2021 to February 1, 2023

• SI BP phase (binary)

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

  November 1, 2021 to February 1, 2023

• SI D phase (binary)

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

  November 1, 2021 to February 1, 2023

• SI SUV (Standardized Uptake Values) BP phase

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

  November 1, 2021 to February 1, 2023

• Thoracolumbar SUV (Standardized Uptake Values) BP phase

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

  November 1, 2021 to February 1, 2023

• SI SUV D phase

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

  November 1, 2021 to February 1, 2023

• Thoracolumbar SUV D phase

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

  November 1, 2021 to February 1, 2023

• Thoracolumbar MRI (binary)

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

  November 1, 2021 to February 1, 2023

• Thoracolumbar BP phase (binary)

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

  November 1, 2021 to February 1, 2023

• Thoracolumbar D phase (binary)

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

  November 1, 2021 to February 1, 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

78 patients with SPECT-CT Among them : 51 patients with axial MRI (spine n=42 and/or sacroiliac joints n=47) : * 1 excluded for extravasation of contrast agent at the injection site * 1 excluded for "blood- pool phase" SPECT missing For 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… For 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nancy University Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (3)

• 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: 24351517 BACKGROUND

• 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: 27050638 BACKGROUND

• 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.

  PMID: 28976332 BACKGROUND

MeSH Terms

Conditions

Spondylarthritis; Sacroiliitis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Caroline MORIZOT, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rhumatology

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: November 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)