Characterizing SAPHO With 68Ga-FAPI PET/CT
Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2020
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2020
CompletedFirst Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedOctober 23, 2020
October 1, 2020
12 months
October 15, 2020
October 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Metabolic parameters
through study completion, an average of 1 year
FAPI expression and SUV
through study completion, an average of 1 year
Disease burden assessement
through study completion, an average of 1 year
Study Arms (1)
68Ga-FAPI PET/CT
EXPERIMENTALInject 68Ga-FAPI and then perform PET/CT scan.
Interventions
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.
Eligibility Criteria
You may qualify if:
- suspected or confirmed untreated SAPHO 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, Dongcheng, 100010, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongli Jing, MD
Peking Union Medical College Hospital
Central Study Contacts
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
October 15, 2020
First Posted
October 22, 2020
Study Start
June 8, 2020
Primary Completion
June 1, 2021
Study Completion
July 1, 2021
Last Updated
October 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share