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Clinical Study of 18F-FAPI-RGD PET/CT in Rheumatoid Arthritis

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05944198
Collaborator
(none)
30
Enrollment
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about 18F-FAPI-RGD PET/CT imaging in assessing rheumatoid arthritis disease activity. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with rheumatoid arthritis who met the 2010 American College of Rheumatology/European League against Rheumatism Rheumatoid arthritis classification criteria will be included. All patients will be assessed for disease activity and the clinical disease activity Index (cDAI) was calculated. Blood sedimentation rate and CRP assay results will be collected. All patients will undergo 18F-FAPI-RGD PET/CT examination. The correlation of cDAI, ESR and CRP levels with PET joint count and PET joint index as measured by 18F-FAPI-RGD PET/CT will be statistically analyzed.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Study of 18F-labeled Probes Targeting Fibroblast Activating Protein and Integrin avĪ²3 (FAPI-RGD) to Assess Disease Activity in Rheumatoid Arthritis
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between clinical indicators and PET/CT results [1 month]

      Correlation of clinical disease activity Index (cDAI), erythrocyte sedimentation rate (ESR), and CRP levels with 18F-FAPI-RGD PET/CT results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.
    Exclusion Criteria:
      1. Patients with malignant tumors and other rheumatic immune diseases; B. clinical and conventional radiographic inspection of materials; C. researchers think not suitable for other information to participate in this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Wang, Associate senior physician, Sichuan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05944198
    Other Study ID Numbers:
    • SichuanPPH-RA
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jul 13, 2023