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Recruiting NCT05657847

Novel Complex Radiodiagnostics of Peripherial Arthropathies

Observational Arthritis, Rheumatoid Arthritis, Psoriatic Crystal Arthropathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photon-counting detector-CT.
Who it may be relevant to
Registry conditions: Arthritis, Rheumatoid, Arthritis, Psoriatic, Crystal Arthropathies. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Chronic peripherial arthritides are common diseases with soaring public health consequences. Our goal is to assess the role of photon-counting detector computed tomography in the diagnostics of peripherial arthropathies.

Detailed description

Background:

Chronic peripherial arthritides include immune-mediated (rheumatoid arthritis, psoriatic arthritis) and crystal deposition diseases (gout, pseudogout, hydroxiapatite-deposition disease).

Conventional radiographs are utilized to screen arthritis-associated deformities, bone erosions and joint space narrowing. MRI is able to detect bone marrow edema, synovitis and the swelling of soft tissues. Sonography can also detect synovitis and soft tissue involvement but does not provide information about bone marrow edema and poorly assess erosions. Photon-counting detector computed tomography (PCD-CT) is a novel type of CT device which provides many advantages like improved signal-to-noise ratio, intrinsic spectral information, lower radiation exposure, and better spatial resolution. PCD-CT is a type of X-ray computed tomography in which X-rays are detected using a photon-counting detector. These detectors are able to directly transform X-ray photons into electrical signals. Compared to previous generation scintillation detectors, photon-counting detectors have several advantages: being able to count the charges created by individual x-ray photons and measuring their energy level also providing multi- energy spectral sensitivity. 0.2 mm slice thickness potentiates the detection of bone erosionss. Collagen-rich structures like cartilage, ligaments, and tendons are easier to identify on PCD-CT images. Bone marrow edema can be visualized with virtual non- calcium reconstruction. PCD-CT could both detect and differentiate cristal deposits.

Aims: To assess the possible role of PCD-CT technique in the diagnostics of peripherial arthropathies.To compare the role of PCD-CT in the detection of arthritis-related pathologies with other imaging modalities like MRI and conventional radiography.

Interventions

  • Device Photon-counting detector-CT
    CT scan

Primary outcome measures

  • Bone erosions [Time frame: From baseline to at least 2 years]
  • Bone marrow edema and periarticular soft tissue involvement [Time frame: From baseline to at least 2 years]
  • Crystal deposit characterization [Time frame: From baseline to at least 2 years]
Secondary outcome measures (1)
  • To evaluate the performance of PCD-CT in the detection of active arthritis-related imaging findings and structural damages. [Time frame: From baseline to at least 3 years]

Eligibility criteria

Inclusion criteria

  • Rheumatoid arthritis (EULAR/ACR Criteria) / Psoriatic arthritis (CASPAR Criteria)/ Crystal arthropathies
  • signed informed consent

Exclusion criteria

  • age: <18 years, > 100 years
  • pregnant
  • breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Hungary · 3 centers
  • National Institute of Rheumatology and Physiotherapy — Budapest
  • Buda Hospital of the Hospitaller Order of Saint John of God — Budapest
  • Semmelweis University — Budapest

Publications

  • Duryea J, Dobbins JT 3rd, Lynch JA. Digital tomosynthesis of hand joints for arthritis assessment. Med Phys. 2003 Mar;30(3):325-33. doi: 10.1118/1.1543573. PMID 12674232
  • Stamp LK, Anderson NG, Becce F, Rajeswari M, Polson M, Guyen O, Viry A, Choi C, Kirkbride TE, Raja AY. Clinical Utility of Multi-Energy Spectral Photon-Counting Computed Tomography in Crystal Arthritis. Arthritis Rheumatol. 2019 Jul;71(7):1158-1162. doi: 10.1002/art.40848. Epub 2019 May 28. PMID 30714678
  • Adams JE, Chen SZ, Adams PH, Isherwood I. Measurement of trabecular bone mineral by dual energy computed tomography. J Comput Assist Tomogr. 1982 Jun;6(3):601-7. doi: 10.1097/00004728-198206000-00028. PMID 7096705
  • Woodworth TG, Morgacheva O, Pimienta OL, Troum OM, Ranganath VK, Furst DE. Examining the validity of the rheumatoid arthritis magnetic resonance imaging score according to the OMERACT filter-a systematic literature review. Rheumatology (Oxford). 2017 Jul 1;56(7):1177-1188. doi: 10.1093/rheumatology/kew445. PMID 28398508
  • Ostergaard M, Ejbjerg B, Szkudlarek M. Imaging in early rheumatoid arthritis: roles of magnetic resonance imaging, ultrasonography, conventional radiography and computed tomography. Best Pract Res Clin Rheumatol. 2005 Feb;19(1):91-116. doi: 10.1016/j.berh.2004.08.006. PMID 15588973
  • Fukuda T, Umezawa Y, Asahina A, Nakagawa H, Furuya K, Fukuda K. Dual energy CT iodine map for delineating inflammation of inflammatory arthritis. Eur Radiol. 2017 Dec;27(12):5034-5040. doi: 10.1007/s00330-017-4931-8. Epub 2017 Jul 3. PMID 28674965
  • Mallinson PI, Coupal TM, McLaughlin PD, Nicolaou S, Munk PL, Ouellette HA. Dual-Energy CT for the Musculoskeletal System. Radiology. 2016 Dec;281(3):690-707. doi: 10.1148/radiol.2016151109. PMID 27870622
  • Finkenstaedt T, Manoliou A, Toniolo M, Higashigaito K, Andreisek G, Guggenberger R, Michel B, Alkadhi H. Gouty arthritis: the diagnostic and therapeutic impact of dual-energy CT. Eur Radiol. 2016 Nov;26(11):3989-3999. doi: 10.1007/s00330-016-4237-2. Epub 2016 Feb 4. PMID 26847043

Identifiers

NCT: NCT05657847 · IV/664-3/2022/EKU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗