Novel Complex Radiodiagnostics of Peripherial Arthropathies

December 12, 2022 updated by: Semmelweis University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, H-1023
        • Recruiting
        • National Institute of Rheumatology and Physiotherapy
        • Contact:
          • Peter Vince Balint, MD, PhD, FRCP
          • Phone Number: +36 1 438 8300
          • Email: pvbalint@gmail.com
        • Principal Investigator:
          • Peter Vince Balint, MD, PhD, FRCP
        • Sub-Investigator:
          • Viktoria Gyergyoi, MD
        • Sub-Investigator:
          • Akos Menyhart, MD
      • Budapest, Hungary, H-1027
        • Recruiting
        • Buda Hospital of the Hospitaller Order of Saint John of God
        • Contact:
        • Principal Investigator:
          • Gyorgy Sandor Nagy, MD, PhD
        • Sub-Investigator:
          • Judit Zsuzsanna Majnik, MD, PhD
        • Sub-Investigator:
          • Kinga Fritsch, MD
      • Budapest, Hungary, H-1085
        • Recruiting
        • Semmelweis University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pal Maurovich-Horvat, MD, PhD, MPH
        • Sub-Investigator:
          • Nikolett Marton, MD, PhD
        • Sub-Investigator:
          • Janos Gyebnar, MD
        • Sub-Investigator:
          • Gyorgy Gulacsi, MD
        • Sub-Investigator:
          • Rita Csercsik, MD
        • Sub-Investigator:
          • Norbert Nagy, MD
        • Sub-Investigator:
          • Tamas Nemeth, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults suffering from peripherial arthritis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone erosions
Time Frame: From baseline to at least 2 years
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
Time Frame: 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.
From baseline to at least 2 years
Crystal deposit characterization
Time Frame: From baseline to at least 2 years
To detect the different crystal deposits with PCD-CT.
From baseline to at least 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the performance of PCD-CT in the detection of active arthritis-related imaging findings and structural damages.
Time Frame: From baseline to at least 3 years
To compare the performance of PCD-CT with different modalities in the diagnostics of peripherial arthropathies.
From baseline to at least 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Anticipated)

February 1, 2027

Study Completion (Anticipated)

February 1, 2027

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV/664-3/2022/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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