Characterizing SAPHO With 68Ga-FAPI PET/CT

Early Phase 1

• Conditions: SAPHO Syndrome
• Interventions: Drug: 68Ga-FAPI

• Registration Number: NCT04596462
• Lead Sponsor: Peking Union Medical College Hospital

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. 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-08
• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic value	through study completion, an average of 1 year	Sensitivity and Specificity of 68Ga-FAPI PET/CT for SAPHO in comparison with 18F-FDG PET/CT

Secondary Outcome Measures

Name	Time	Method
Metabolic parameters	through study completion, an average of 1 year	Total Lesion Glycolysis (TLG) of SAPHO lesions are measured on 68Ga-FAPI PET/CT.
FAPI expression and SUV	through study completion, an average of 1 year	Correlation between FAPI expression and SUV in PET
Disease burden assessement	through study completion, an average of 1 year	Correlation between Total Lesion Glycolysis (TLG) of bone lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for SAPHO

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Dongcheng, China