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Characterizing SAPHO With 68Ga-FAPI PET/CT

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ClinicalTrials.gov Identifier: NCT04596462
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
SAPHO Syndrome Drug: 68Ga-FAPI Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021


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 SAPHO by PET/CT.
Other Name: 68Ga-fibroblast activating protein inhibitors




Primary Outcome Measures :
  1. Diagnostic value [ Time Frame: 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 :
  1. Metabolic parameters [ Time Frame: through study completion, an average of 1 year ]
    Total Lesion Glycolysis (TLG) of SAPHO lesions are measured on 68Ga-FAPI PET/CT.

  2. FAPI expression and SUV [ Time Frame: through study completion, an average of 1 year ]
    Correlation between FAPI expression and SUV in PET

  3. Disease burden assessement [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596462


Contacts
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Contact: Peipei Wang, MD 18511395988 wpp199411@163.com
Contact: Guozhu Hou, MD 15611145656 15611145656@163.com

Locations
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China, Dongcheng
Peking union medical college hospital Recruiting
Beijing, Dongcheng, China, 100010
Contact: Peipei Wang, MD    18511395988    wpp199411@163.com   
Contact: Guozhu Hou, MD    15611145656    15611145656@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Hongli Jing, MD Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04596462    
Other Study ID Numbers: PekingUMCHFAPISAPHO
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Hyperostosis Syndrome
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases