Psoriatic ArthritisEarly Phase 1NCT05686876
FAPI-PET/CT in Psoriatic Arthritis
A Early Phase 1 study testing 68Ga-FAPI in people with Psoriatic Arthritis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- 68Ga-FAPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 28 Feb 2023
- Phase
- Early Phase 1
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR)
- 18F-NAF PET/CT within two weeks
- signed written consent.
Who cannot join
- pregnancy
- breast feeding
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
Xiaomei Leng, +8613681057089, lpumch@126.com
About this study
Official title: Fibroblast Activation Protein-Targeted PET/CT With 68Ga-FAPI for Imaging Psoriatic Arthritis: Comparison to 18F-NAF PET/CT
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease. Therefore, this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.
Read the detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory disease that develops in up to 30% of patients with psoriasis and characterized by diverse clinical features including peripheral and axial arthritis, enthesitis, dactylitis and nail dystrophy, leading to impaired function and reduced quality of life. Positron emission tomography (PET) allows for highly sensitive depiction of targets at the molecular level and can be used to specifically visualize immune cells of interest through the use of specific tracers. In this study, we used two tracers: 68Ga-fibroblast activation protein inhibitor (FAPI) and 18F-sodium fluoride (18F-NaF) to evaluate both joint inflammation and bone metabolism in patients with PsA. And the study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.
- Conditions
- Psoriatic Arthritis
- Being tested
- 68Ga-FAPI
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPIDrug
Also called 68Ga-fibroblast activating protein inhibitors
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of PsA by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI, PET/CT | Experimental | Inject 68Ga-FAPI and then perform PET/CT scan. Receives: Drug: 68Ga-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Diagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT.
Measured: Through study completion, an average of 3months
Secondary outcomes (1)
Disease activity assessment
Correlation between disease activity assessed on 68Ga-FAPI PET/CT and clinical parameters for PsA.
Measured: Through study completion, an average of 3months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Nov 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686876
- Sponsor's protocol ID
- LXM-230107
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang F, Lu C, Pan Q, Zhang R, Yang M, Wang Q, Li M, Zeng X, Luo Y, Leng X. 68Ga-FAPI and 18F-NaF PET/CT in psoriatic arthritis: a comparative study. Rheumatology (Oxford). 2025 May 1;64(5):2575-2582. doi: 10.1093/rheumatology/keae577.
PubMed 39576694
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Activation Protein-Targeted PET/CT With 68Ga-FAPI for Imaging Psoriatic Arthritis: Comparison to 18F-NAF PET/CT
- ClinicalTrials.gov ID
- NCT05686876
- Acronym / sponsor ID
- LXM-230107
- Conditions
- Psoriatic Arthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 17 Jan 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.
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease. Therefore, this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.
Detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory disease that develops in up to 30% of patients with psoriasis and characterized by diverse clinical features including peripheral and axial arthritis, enthesitis, dactylitis and nail dystrophy, leading to impaired function and reduced quality of life. Positron emission tomography (PET) allows for highly sensitive depiction of targets at the molecular level and can be used to specifically visualize immune cells of interest through the use of specific tracers. In this study, we used two tracers: 68Ga-fibroblast activation protein inhibitor (FAPI) and 18F-sodium fluoride (18F-NaF) to evaluate both joint inflammation and bone metabolism in patients with PsA. And the study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI, PET/CT | Experimental | Drug: 68Ga-FAPIInject 68Ga-FAPI and then perform PET/CT scan. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR)
- 18F-NAF PET/CT within two weeks
- signed written consent.
Key exclusion criteria (4 listed)
- pregnancy
- breast feeding
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPIAlso: 68Ga-fibroblast activating protein inhibitorsIntravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of PsA by PET/CT. | Drug | 68Ga-FAPI, PET/CT |
Primary outcome
Diagnostic value
Time frame: Through study completion, an average of 3months
Diagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT.
1 secondary outcome
Disease activity assessment
Time frame: Through study completion, an average of 3months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 39576694Yang F, Lu C, Pan Q, Zhang R, Yang M, Wang Q, Li M, Zeng X, Luo Y, Leng X. 68Ga-FAPI and 18F-NaF PET/CT in psoriatic arthritis: a comparative study. Rheumatology (Oxford). 2025 May 1;64(5):2575-2582. doi: 10.1093/rheumatology/keae577.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-FAPI in people with Psoriatic Arthritis, run by Peking Union Medical College 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Leng, MD (+8615811217379, lpumch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: Through study completion, an average of 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686876, which also lists 1 linked publication.
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 17 Jan 2023.