FAPI-PET/CT in Psoriatic Arthritis

NCT ID: NCT05686876

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-02-28

Brief Summary

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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

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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

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Psoriatic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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68Ga-FAPI, PET/CT

Inject 68Ga-FAPI and then perform PET/CT scan.

Group Type EXPERIMENTAL

68Ga-FAPI

Intervention Type DRUG

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.

Interventions

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68Ga-FAPI

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.

Intervention Type DRUG

Other Intervention Names

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68Ga-fibroblast activating protein inhibitors

Eligibility Criteria

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Inclusion Criteria

* fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR)
* 18F-NAF PET/CT within two weeks
* signed written consent.

Exclusion Criteria

* pregnancy
* breast feeding
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaomei Leng, MD

Role: CONTACT

+8615811217379

Facility Contacts

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Xiaomei Leng

Role: primary

+8613681057089

References

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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.

Reference Type DERIVED
PMID: 39576694 (View on PubMed)

Other Identifiers

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LXM-230107

Identifier Type: -

Identifier Source: org_study_id

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