Clinical trial NCT05657847: Novel Complex Radiodiagnostics of Peripherial Arthropathies
Official title: Novel Complex Radiodiagnostics of Peripherial Arthropathies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis, Rheumatoid
Arthritis, Psoriatic
Crystal Arthropathies
Keywords: photon-counting detector computer tomography, magnetic resonance imaging, radiography, rheumatoid arthritis, psoriatic arthritis, crystal arthropathies
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: National Institute of Rheumatology and Physiotherapy, Hungary
name: Buda Hospital of the Hospitaller Order of Saint John of God
First posted: 2022-12-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults suffering from peripherial arthritis.

Brief summary: 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.

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

Primary outcomes:
measure: Bone erosions
timeFrame: From baseline to at least 2 years
measure: Bone marrow edema and periarticular soft tissue involvement
timeFrame: From baseline to at least 2 years
measure: Crystal deposit characterization
timeFrame: From baseline to at least 2 years
Secondary outcomes:
measure: To evaluate the performance of PCD-CT in the detection of active arthritis-related imaging findings and structural damages.
timeFrame: From baseline to at least 3 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Rheumatology and Physiotherapy
city: Budapest
country: Hungary
facility: Buda Hospital of the Hospitaller Order of Saint John of God
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
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