NCT05999643

Brief Summary

To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation evaluation and prognosis prediction in spondyloarthritis.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

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

July 1, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

July 30, 2023

Last Update Submit

August 13, 2023

Conditions

SpondyloarthritisAxial SpondyloarthritisAnkylosing Spondylitis

Keywords

SpondyloarthritisAxial SpondyloarthritisAnkylosing Spondylitis68Ga-FAPI

Outcome Measures

Primary Outcomes (1)

  • To define the distribution pattern of 68Ga-FAPI in SpA patients.

    To quantify 68Ga-FAPI tracer biodistribution in characteristic inflammatory tissue including SI joints, spine, and the peripheral joints versus conventional x ray examination or magnetic resonance imaging (MRI) techniques in adult active SpA. 68Ga-FAPI PET tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).

    60 minutes following injection

Secondary Outcomes (3)

  • Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.

    30 days

  • Correlation between uptake of 68GA-FAPI change and disease activity change

    Up to 2 years

  • Correlation between uptake of 68GA-FAPI and therapy response

    Up to 2 years

Study Arms (1)

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

EXPERIMENTAL

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

Diagnostic Test: Drug: 68Ga-FAPI

Interventions

Drug: 68Ga-FAPIDIAGNOSTIC_TEST

Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image SpA lesions in SI joints, spine, musculoskeletal and the extra-articular involvement by PET/CT.

Also known as: 68Ga-fibroblast activating protein inhibitors
Inject 68Ga-FAPI and then perform PET/CT scan.

Eligibility Criteria

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

You may qualify if:

  • A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis International Society) classification criteria for SpA.
  • Adult men or women 18 and ≤ 65 years of age at the time of signing the informed consent (ICF).
  • participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

  • Pregnancy;
  • Breastfeeding;
  • 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)

The first affiliated hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Related Publications (1)

  • Chen Y, Yu L, Chen S, Liu W, Han H, Pang Y, Lin Q, Li Y, Chen L, Cai J, Zhao L, Sun L, Shi G, Chen H, Liu Y. Fibroblast activation protein-targeted PET/CT with 68Ga-FAPI-46 for evaluation of structural damage and inflammation in axial spondyloarthritis: a prospective study. Eur J Nucl Med Mol Imaging. 2025 Oct;52(12):4661-4673. doi: 10.1007/s00259-025-07310-2. Epub 2025 May 1.

    PMID: 40310563DERIVED

MeSH Terms

Conditions

SpondylarthritisAxial SpondyloarthritisSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSpondylarthropathiesAnkylosis

Study Officials

  • Guixiu Shi, PhD

    The First Affiliated Hospital of Xiamen University

    STUDY DIRECTOR

Central Study Contacts

Yuan Liu, MD

CONTACT

86 0592-2137749iuyuan@xmu.edu.cn

Haojun Chen, PhD

CONTACT

86 0592-2137166leochen0821@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 21, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2025

Last Updated

August 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)