Characterizing Rheumatoid Arthritis With 68Ga-FAPI 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 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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis
• Intervention / Treatment: Drug: 68Ga-FAPI

Detailed Description

Arthritis is a term used to mean any disorder that affects the joints. The two most common forms of arthritis are osteoarthritis and rheumatoid arthritis.Rheumatoid arthritis is an autoimmune chronic inflammatory disease of unknown etiology and is characterized by chronic inflammation of the joint capsule's synovial membrane. This chronic inflammation ultimately destroys the underlying cartilage and bone. Activated fibroblast-like synoviocytes (FLS) line the synovial membrane and are a prominent cell type responsible for inflammation and joint destruction. Osteoarthritis is characterized by degradation of joint cartilage. Studies demonstrate chondrocytes expressed FAP and that chondrocyte FAP expression was elevated in patients with osteoarthritis. Other researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients. However, FAP expression was greater in samples taken from refractory rheumatoid arthritis patients in comparison to end-stage osteoarthritis patients.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. Recently the investigators have published an article of the application of 68Ga-FAPI in IgG4-related disease which showed it was more sensitive than FDG in detecting a certain type of inflammations. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yaping Luo, MD; Phone Number: 86-10-69155513; Email: luoyaping@live.com
• Study Contact Backup: Name: Qingqing Pan, MD; Phone Number: 86-10-69155513; Email: pqqelvay@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yaping Luo, MD; Phone Number: 86-10-69155513; Email: luoyaping@live.com
      • Contact: Qingqing Pan; Phone Number: 86-10-69155513; Email: pqqelvay@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• suspected or confirmed untreated arthritis patients;
• 18F-FDG PET/CT within two weeks;
• signed written consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-FAPI, PET/CT; Inject 68Ga-FAPI and then perform PET/CT scan.	Drug: 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 arthritis by PET/CT.; Other Names: 68Ga-fibroblast activating protein inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FAPI expression and SUV	Correlation between FAPI expression and SUV in PET	through study completion, an average of 1 year
Metabolic parameters	Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT.	Time Frame: through study completion, an average of 1 year
Disease burden assessement	whether Total Lesion Glycolysis (TLG) assessed on 68Ga-FAPI PET/CT was correlated with clinical parameters for arthritis using correlation coefficients analysis	through study completion, an average of 1 year
Therapy response	Change of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yaping Luo, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: PekingUMCHFAPIRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No