Characterizing SAPHO With 68Ga-FAPI PET/CT

SAPHO Syndrome Clinical Trial

Official title:

Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596462
• Other study ID #: PekingUMCHFAPISAPHO
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 8, 2020
• Est. completion date: July 2021

Study information

• Verified date: October 2020
• Source: Peking Union Medical College Hospital
• Contact: Peipei Wang, MD
• Phone: 18511395988
• Email: wpp199411[@]163.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. 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 SAPHO than 18F-FDG PET/CT.

Description:

Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 18F-FDG PET/CT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• suspected or confirmed untreated SAPHO 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

• SAPHO Syndrome

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 SAPHO by PET/CT.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Dongcheng

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 SAPHO in comparison with 18F-FDG PET/CT	through study completion, an average of 1 year
Secondary	Metabolic parameters	Total Lesion Glycolysis (TLG) of SAPHO lesions are measured on 68Ga-FAPI PET/CT.	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	Disease burden assessement	Correlation between Total Lesion Glycolysis (TLG) of bone lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for SAPHO	through study completion, an average of 1 year