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NCT05657847 Clinical Trial

Novel Complex Radiodiagnostics of Peripherial Arthropathies

Arthritis, Rheumatoid Clinical Trial

Official title:
Novel Complex Radiodiagnostics of Peripherial Arthropathies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05657847
Other study ID # IV/664-3/2022/EKU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 7, 2022
Est. completion date February 1, 2027

Study information
Verified date July 2022
Source Semmelweis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date February 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Photon-counting detector-CT
CT scan

Locations
Country Name City State
Hungary Buda Hospital of the Hospitaller Order of Saint John of God Budapest
Hungary National Institute of Rheumatology and Physiotherapy Budapest
Hungary Semmelweis University Budapest

Sponsors (3)
Lead Sponsor Collaborator
Semmelweis University Buda Hospital of the Hospitaller Order of Saint John of God, National Institute of Rheumatology and Physiotherapy, Hungary

Country where clinical trial is conducted

Hungary, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Willemink MJ, Persson M, Pourmorteza A, Pelc NJ, Fleischmann D. Photon-counting CT: Technical Principles and Clinical Prospects. Radiology. 2018 Nov;289(2):293-312. doi: 10.1148/radiol.2018172656. Epub 2018 Sep 4. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Bone erosions To assess the detection of arthritis-related bone erosions with different imaging techniques, including PCD-CT. From baseline to at least 2 years
Primary Bone marrow edema and periarticular soft tissue involvement To assess the detection of arthritis-related bone marrow edema and periarticular soft tissue with different imaging techniques, including PCD-CT. From baseline to at least 2 years
Primary Crystal deposit characterization To detect the different crystal deposits with PCD-CT. From baseline to at least 2 years
Secondary To evaluate the performance of PCD-CT in the detection of active arthritis-related imaging findings and structural damages. To compare the performance of PCD-CT with different modalities in the diagnostics of peripherial arthropathies. From baseline to at least 3 years
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