Arthritis, RheumatoidNCT05657847
Novel Complex Radiodiagnostics of Peripherial Arthropathies
An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Semmelweis University at 3 sites in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Crystal Arthropathies
- What is being tested?
- Photon-counting detector-CT
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 3 sitesHungary
- Study dates
- 7 Mar 2022to 1 Feb 2027
- Phase
- Observational
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 to 100 years
- All sexes
- Adult, Older adult
Study population: Adults suffering from peripherial arthritis.
Who may be able to join
- Rheumatoid arthritis (EULAR/ACR Criteria) / Psoriatic arthritis (CASPAR Criteria)/ Crystal arthropathies
- signed informed consent
Who cannot join
- age: <18 years, > 100 years
- pregnant
- breastfeeding
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary3 sites, 3 recruiting
- Recruiting
National Institute of Rheumatology and Physiotherapy
Budapest, H-1023
Peter Vince Balint, MD, PhD, FRCP, +36 1 438 8300, pvbalint@gmail.com
Peter Vince Balint, MD, PhD, FRCP
- Recruiting
Buda Hospital of the Hospitaller Order of Saint John of God
Budapest, H-1027
Gyorgy Nagy, MD, PhD, +36-1-438 8500, gyorgyngy@gmail.com
Gyorgy Sandor Nagy, MD, PhD
- Recruiting
Semmelweis University
Budapest, H-1085
Pal Maurovich-Horvat, MD, PhD, MPH, +36-1-210-0307, maurovich-horvat.pal@med.semmelweis-univ.hu
Nikolett Marton, MD, PhD, +36-30-016-4545, marton.nikol@gmail.com
About this study
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.
Read the 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.
- Being tested
- Photon-counting detector-CT
- Keywords
- photon-counting detector computer tomography, magnetic resonance imaging, radiography, rheumatoid arthritis, psoriatic arthritis, crystal arthropathies
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Crystal Arthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon-counting detector-CTDevice
CT scan
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | 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) Receives: Device: Photon-counting detector-CT | |
| Psoriatic arthritis | 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. Receives: Device: Photon-counting detector-CT | |
| Crystal arthropathies | 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. Receives: Device: Photon-counting detector-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone erosions
To assess the detection of arthritis-related bone erosions with different imaging techniques, including PCD-CT.
Measured: From baseline to at least 2 years
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.
Measured: From baseline to at least 2 years
Crystal deposit characterization
To detect the different crystal deposits with PCD-CT.
Measured: From baseline to at least 2 years
Secondary outcomes (1)
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.
Measured: From baseline to at least 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start7 Mar 2022
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Rheumatology and Physiotherapy, Hungary, Buda Hospital of the Hospitaller Order of Saint John of God
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657847
- Sponsor's protocol ID
- IV/664-3/2022/EKU
- Status last verified
- Jul 2022
- First submitted
- 12 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided
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.
PubMed 12674232Stamp 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.
PubMed 30714678Adams 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.
PubMed 7096705Woodworth 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.
PubMed 28398508Ostergaard 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.
PubMed 15588973Fukuda 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.
PubMed 28674965Mallinson 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.
PubMed 27870622Finkenstaedt 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.
PubMed 26847043Willemink 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.
PubMed 30179101