Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT

Arthritis Clinical Trial

Official title:

Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04514614
• Other study ID #: PekingUMCHFAPIRA
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2021
• Source: Peking Union Medical College Hospital
• Contact: Yaping Luo, MD
• Phone: 86-10-69155513
• Email: luoyaping[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	FAPI expression and SUV	Correlation between FAPI expression and SUV in PET	through study completion, an average of 1 year
Secondary	Therapy response	Change of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy	through study completion, an average of 1 year