Characterizing IgG4-RD With 68Ga-FAPI PET/CT
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|ClinicalTrials.gov Identifier: NCT04125511|
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|IgG4-related Disease||Drug: 68Ga-FAPI||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||December 1, 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 IgG4-RD by PET/CT.
Other Name: 68Ga-fibroblast activating protein inhibitors
- Metabolic parameters [ Time Frame: through study completion, an average of 1 year ]Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT.
- Diagnostic value [ Time Frame: through study completion, an average of 1 year ]Diagnostic value of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT.
- adverse events [ Time Frame: through study completion, an average of 1 year ]Number of participants and kind of adverse events as a measure of safety.
- Disease burden assessement [ Time Frame: through study completion, an average of 1 year ]Correlation between disease burden assessed on 68Ga-FAPI PET/CT and clinical parameters for IgG4-RD.
- FAPI expression and SUV [ Time Frame: through study completion, an average of 1 year ]Correlation between FAPI expression and SUV in PET
- Prediction value [ Time Frame: through study completion, an average of 1 year ]Prediction value of 68Ga-FAPI PET/CT for IgG4-RD in therapy response assessment
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): NCT04125511
|Contact: Li Huo, M.D.||firstname.lastname@example.org|
|Contact: Yaping Luo, M.D.||email@example.com|
|Principal Investigator:||Li Huo, M.D.||Peking Union Medical College Hospital|