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CompletedNCT05944198Updated Jul 15, 2024

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

An observational study in Rheumatoid Arthritis, sponsored by Sichuan Provincial People's Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Sichuan Provincial People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,963 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 40 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Sichuan Provincial People's Hospital is the lead sponsor of 78 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Correlation between clinical indicators and PET/CT results

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

    Time frame: 1 month

07

Study locations

1 site
  • Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Feb 2024, 7 months.

Of 196 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 96. This study's 7 months is below that.

Counting every sponsor, half of 317 studies reached it within 47 months; a quarter within 24 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2023
First posted
Jul 13, 2023
StartActual
Jul 14, 2023
Primary completionActual
Feb 20, 2024
CompletionActual
Feb 20, 2024
Last update
Jul 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05944198
Lead sponsor
Sichuan Provincial People's Hospital
Responsible party
Hao Wang (Associate senior physician, Sichuan Provincial People's Hospital) — Principal investigator
First posted
Jul 13, 2023
Start date
Jul 14, 2023
Primary completion
Feb 20, 2024
Completion
Feb 20, 2024
Last update
Jul 15, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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