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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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

  • 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

    Recruiting

Other trials in Hungary

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 groups in NCT05657847
Study groupRoleWhat they receive
Rheumatoid arthritisRheumatoid 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 arthritisPsoriatic 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 arthropathiesCrystal 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.

  1. 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

  2. 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

  3. Crystal deposit characterization

    To detect the different crystal deposits with PCD-CT.

    Measured: From baseline to at least 2 years

Secondary outcomes (1)

  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.

  1. First posted20 Dec 2022
  2. Study start7 Mar 2022
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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)
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 26847043

  • 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.

    PubMed 30179101

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Semmelweis University at 3 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone erosions (time frame: From baseline to at least 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05657847, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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