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SpondyloarthritisASOCENCT06198361

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

An observational study of Spondyloarthritis, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spondyloarthritis
How many people
47 participants
Where
1 siteFrance
Study dates
1 Nov 2021to 1 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nancy University Hospital

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

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

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.

Read more

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.

Read the detailed description

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.

Keywords
spondyloarthritis, sacroiliitis, sacroiliac joints, VERITON-CT, SPECT-CT, thoracolumbar spine
Medical subject headings
Spondylarthritis, Sacroiliitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SI MRI (binary)

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

    Measured: November 1, 2021 to February 1, 2023

  2. 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

    Measured: November 1, 2021 to February 1, 2023

  3. SI BP phase (binary)

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

    Measured: November 1, 2021 to February 1, 2023

  4. SI D phase (binary)

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

    Measured: November 1, 2021 to February 1, 2023

  5. SI SUV (Standardized Uptake Values) BP phase

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

    Measured: November 1, 2021 to February 1, 2023

  6. Thoracolumbar SUV (Standardized Uptake Values) BP phase

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

    Measured: November 1, 2021 to February 1, 2023

  7. SI SUV D phase

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

    Measured: November 1, 2021 to February 1, 2023

  8. Thoracolumbar SUV D phase

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

    Measured: November 1, 2021 to February 1, 2023

  9. Thoracolumbar MRI (binary)

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

    Measured: November 1, 2021 to February 1, 2023

  10. Thoracolumbar BP phase (binary)

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

    Measured: November 1, 2021 to February 1, 2023

  11. Thoracolumbar D phase (binary)

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

    Measured: November 1, 2021 to February 1, 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start1 Nov 2021
  3. Primary completion1 Feb 2023
  4. Study completion1 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06198361
Sponsor's protocol ID
2023PI091
Acronym
ASOCE
Status last verified
Jul 2024
First submitted
27 Dec 2023
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24351517

  • 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.

    PubMed 27050638

  • 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.

    PubMed 28976332

Questions about this trial

What is this clinical trial studying?

An observational study of Spondyloarthritis, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SI MRI (binary) (time frame: November 1, 2021 to February 1, 2023). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06198361, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

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