Novel Complex Radiodiagnostics of Peripherial Arthropathies

NCT ID: NCT05657847

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-07

Study Completion Date

2027-02-01

Brief Summary

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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

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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.

Conditions

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Arthritis, Rheumatoid Arthritis, Psoriatic Crystal Arthropathies

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Photon-counting detector-CT

Intervention Type DEVICE

CT scan

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.

Photon-counting detector-CT

Intervention Type DEVICE

CT scan

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.

Photon-counting detector-CT

Intervention Type DEVICE

CT scan

Interventions

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Photon-counting detector-CT

CT scan

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Rheumatology and Physiotherapy, Hungary

UNKNOWN

Sponsor Role collaborator

Buda Hospital of the Hospitaller Order of Saint John of God

UNKNOWN

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Institute of Rheumatology and Physiotherapy

Budapest, , Hungary

Site Status RECRUITING

Buda Hospital of the Hospitaller Order of Saint John of God

Budapest, , Hungary

Site Status RECRUITING

Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Facility Contacts

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Peter Vince Balint, MD, PhD, FRCP

Role: primary

Gyorgy Nagy, MD, PhD

Role: primary

Pal Maurovich-Horvat, MD, PhD, MPH

Role: primary

Nikolett Marton, MD, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 12674232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30714678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7096705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28398508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15588973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28674965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27870622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26847043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30179101 (View on PubMed)

Other Identifiers

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IV/664-3/2022/EKU

Identifier Type: -

Identifier Source: org_study_id