Rheumatoid ArthritisNCT05944198
Clinical Study of 18F-FAPI-RGD PET/CT in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2023to 20 Feb 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.
Who may be able to join
- Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
About this study
Official title: Clinical Study of 18F-labeled Probes Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) to Assess Disease Activity in Rheumatoid Arthritis
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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start14 Jul 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Wang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944198
- Sponsor's protocol ID
- SichuanPPH-RA
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 18F-labeled Probes Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) to Assess Disease Activity in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05944198
- Acronym / sponsor ID
- SichuanPPH-RA
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.
Key inclusion criteria (1 listed)
- Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between clinical indicators and PET/CT results (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.