NCT04514614

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 and inflammatory bowel disease. Some researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients.Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of arthritis than 18F-FDG 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
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2020

Typical duration 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

First Submitted

Initial submission to the registry

August 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

August 7, 2020

Last Update Submit

January 24, 2021

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value

    Sensitivity and Specificity of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT.

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Metabolic parameters

    Time Frame: through study completion, an average of 1 year

  • Disease burden assessement

    through study completion, an average of 1 year

  • FAPI expression and SUV

    through study completion, an average of 1 year

  • Therapy response

    through study completion, an average of 1 year

Study Arms (1)

68Ga-FAPI, PET/CT

EXPERIMENTAL

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

Drug: 68Ga-FAPI

Interventions

68Ga-FAPIDRUG

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 arthritis 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:

  • suspected or confirmed untreated arthritis patients;
  • F-FDG PET/CT within two weeks;
  • signed written consent.

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)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • Yang D, Chen J, He G, Zhou Z, Xu J, Peng Y, Shen X, Jiang X, Pan Q, Zhao L, Fei Y, Luo Y, Yang H. Comparisons of [68 Ga]Ga-FAPI-04 PET/CT with X-ray imaging in the assessment of patients with rheumatoid arthritis. Clin Rheumatol. 2025 Jun;44(6):2191-2199. doi: 10.1007/s10067-025-07414-y. Epub 2025 Apr 28.

    PMID: 40293620DERIVED

  • Pan Q, Yang H, Zhou Z, Li M, Jiang X, Li F, Luo Y, Li M. [68 Ga]Ga-FAPI-04 PET/CT may be a predictor for early treatment response in rheumatoid arthritis. EJNMMI Res. 2024 Jan 4;14(1):2. doi: 10.1186/s13550-023-01064-4.

    PMID: 38175339DERIVED

MeSH Terms

Conditions

Arthritis

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Yaping Luo, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaping Luo, MD

CONTACT

86-10-69155513luoyaping@live.com

Qingqing Pan, MD

CONTACT

86-10-69155513pqqelvay@126.com

Study Design

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

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 17, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2022

Study Completion

December 1, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

CN(1)