NCT05657847

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2022Feb 2027

Study Start

First participant enrolled

March 7, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4.9 years

First QC Date

December 12, 2022

Last Update Submit

December 12, 2022

Conditions

Arthritis, RheumatoidArthritis, PsoriaticCrystal Arthropathies

Keywords

photon-counting detector computer tomography, magnetic resonance imaging, radiography, rheumatoid arthritis, psoriatic arthritis, crystal arthropathies

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Crystal deposit characterization

    To detect the different crystal deposits with PCD-CT.

    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.

    From baseline to at least 3 years

Study Arms (3)

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)

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.

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.

Device: Photon-counting detector-CT

Interventions

Photon-counting detector-CTDEVICE

CT scan

Crystal arthropathiesPsoriatic arthritisRheumatoid arthritis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults suffering from peripherial arthritis.

You may qualify if:

  • Rheumatoid arthritis (EULAR/ACR Criteria) / Psoriatic arthritis (CASPAR Criteria)/ Crystal arthropathies
  • signed informed consent

You may not qualify if:

  • age: \<18 years, \> 100 years
  • pregnant
  • breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Institute of Rheumatology and Physiotherapy

Budapest, H-1023, Hungary

RECRUITING

Buda Hospital of the Hospitaller Order of Saint John of God

Budapest, H-1027, Hungary

RECRUITING

Semmelweis University

Budapest, H-1085, Hungary

RECRUITING

Related Publications (9)

  • 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.

    PMID: 12674232BACKGROUND

  • 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.

    PMID: 30714678BACKGROUND

  • 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.

    PMID: 7096705BACKGROUND

  • 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.

    PMID: 28398508BACKGROUND

  • 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.

    PMID: 15588973BACKGROUND

  • 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.

    PMID: 28674965BACKGROUND

  • 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.

    PMID: 27870622BACKGROUND

  • 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.

    PMID: 26847043BACKGROUND

  • 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.

    PMID: 30179101BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, PsoriaticCrystal Arthropathies

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 20, 2022

Study Start

March 7, 2022

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

December 20, 2022

Record last verified: 2022-07

Locations

HU(3)