Novel Complex Radiodiagnostics of Peripherial Arthropathies

Sponsor
Semmelweis University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05657847
Collaborator
National Institute of Rheumatology and Physiotherapy, Hungary (Other), Buda Hospital of the Hospitaller Order of Saint John of God (Other)
500
3
58.9
166.7
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Photon-counting detector-CT

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Novel Complex Radiodiagnostics of Peripherial Arthropathies
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Feb 1, 2027
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

Arm Intervention/Treatment
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
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.

Device: Photon-counting detector-CT
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.

Device: Photon-counting detector-CT
CT scan

Outcome Measures

Primary Outcome Measures

  1. Bone erosions [From baseline to at least 2 years]

    To assess the detection of arthritis-related bone erosions with different imaging techniques, including PCD-CT.

  2. Bone marrow edema and periarticular soft tissue involvement [From baseline to at least 2 years]

    To assess the detection of arthritis-related bone marrow edema and periarticular soft tissue with different imaging techniques, including PCD-CT.

  3. Crystal deposit characterization [From baseline to at least 2 years]

    To detect the different crystal deposits with PCD-CT.

Secondary Outcome Measures

  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]

    To compare the performance of PCD-CT with different modalities in the diagnostics of peripherial arthropathies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Rheumatology and Physiotherapy Budapest Hungary H-1023
2 Buda Hospital of the Hospitaller Order of Saint John of God Budapest Hungary H-1027
3 Semmelweis University Budapest Hungary H-1085

Sponsors and Collaborators

  • Semmelweis University
  • National Institute of Rheumatology and Physiotherapy, Hungary
  • Buda Hospital of the Hospitaller Order of Saint John of God

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Semmelweis University
ClinicalTrials.gov Identifier:
NCT05657847
Other Study ID Numbers:
  • IV/664-3/2022/EKU
First Posted:
Dec 20, 2022
Last Update Posted:
Dec 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Semmelweis University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2022