NCT05686876

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 7, 2023

Last Update Submit

January 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value

    Diagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT.

    Through study completion, an average of 3months

Secondary Outcomes (1)

  • Disease activity assessment

    Through study completion, an average of 3months.

Study Arms (1)

68Ga-FAPI, PET/CT

EXPERIMENTAL

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

Drug: 68Ga-FAPI

Interventions

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.

Also known as: 68Ga-fibroblast activating protein inhibitors
68Ga-FAPI, PET/CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Xiaomei Leng, MD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2023

First Posted

January 17, 2023

Study Start

November 1, 2022

Primary Completion

January 31, 2023

Study Completion

February 28, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations