Novel Complex Radiodiagnostics of Peripherial Arthropathies

Recruiting

• Conditions: Arthritis, Psoriatic; Arthritis, Rheumatoid; Crystal Arthropathies
• Interventions: Device: Photon-counting detector-CT

• Registration Number: NCT05657847
• Lead Sponsor: Semmelweis University

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.

Study Timeline

• Study Start: 2022-03-07
• Status Verified: 2022-07
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis	Photon-counting detector-CT	Rheumatoid arthritis patients. (American College of Rheumatology (ACR) 1987, ACR/European League Against Rheumatism (EULAR) \>18 years Imaging studies: CT and X-ray/MRI/US Physical examination by the rheumatologist and laboratory tests which are conventionally necessary for the diagnosis (including RF, ACPA)
Psoriatic arthritis	Photon-counting detector-CT	Psoriatic arthritis patients. (CASPAR Criteria) \>18 years Imaging studies: CT and X-ray/MRI/US Physical examination by the rheumatologist and laboratory tests which are conventionally necessary for the diagnosis.
Crystal arthropathies	Photon-counting detector-CT	Crystal arthropathies patients. \>18 years Imaging studies: CT and X-ray/MRI/US Physical examination by the rheumatologist and laboratory tests which are conventionally necessary for the diagnosis.

Primary Outcome Measures

Name	Time	Method
Bone erosions	From baseline to at least 2 years	To assess the detection of arthritis-related bone erosions with different imaging techniques, including PCD-CT.
Bone marrow edema and periarticular soft tissue involvement	From baseline to at least 2 years	To assess the detection of arthritis-related bone marrow edema and periarticular soft tissue with different imaging techniques, including PCD-CT.
Crystal deposit characterization	From baseline to at least 2 years	To detect the different crystal deposits with PCD-CT.

Secondary Outcome Measures

Name	Time	Method
To evaluate the performance of PCD-CT in the detection of active arthritis-related imaging findings and structural damages.	From baseline to at least 3 years	To compare the performance of PCD-CT with different modalities in the diagnostics of peripherial arthropathies.

Trial Locations

Locations (3)

Buda Hospital of the Hospitaller Order of Saint John of God; 🇭🇺 Budapest, Hungary

National Institute of Rheumatology and Physiotherapy; 🇭🇺 Budapest, Hungary

Semmelweis University; 🇭🇺 Budapest, Hungary