Characterizing SAPHO With 68Ga-FAPI PET/CT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04596462|
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|SAPHO Syndrome||Drug: 68Ga-FAPI||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 68Ga-FAPI PET/CT
Inject 68Ga-FAPI and then perform PET/CT scan.
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
- 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
- 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.
- FAPI expression and SUV [ Time Frame: through study completion, an average of 1 year ]Correlation between FAPI expression and SUV in PET
- 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
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
|Contact: Peipei Wang, MDemail@example.com|
|Contact: Guozhu Hou, MDfirstname.lastname@example.org|
|Principal Investigator:||Hongli Jing, MD||Peking Union Medical College Hospital|