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

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ClinicalTrials.gov Identifier: NCT05944198
Recruitment Status : Recruiting
First Posted : July 13, 2023
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Hao Wang, Sichuan Provincial People's Hospital

Study Description
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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
Rheumatoid Arthritis

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Clinical Study of 18F-labeled Probes Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) to Assess Disease Activity in Rheumatoid Arthritis
Actual Study Start Date : July 14, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Correlation between clinical indicators and PET/CT results [ Time Frame: 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
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.
Criteria

Inclusion Criteria:

  • Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.

Exclusion Criteria:

  • A. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944198


Locations
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China, Sichuan
Departments of Nuclear Medicine, Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China, 610072
Contact: Hao Wang, Doctor    +8618313820216    474556259@qq.com   
Sponsors and Collaborators
Sichuan Provincial People's Hospital
More Information
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Responsible Party: Hao Wang, Associate senior physician, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT05944198    
Other Study ID Numbers: SichuanPPH-RA
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases