IgG4-related Disease
Conditions
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,such as IgG4-related disease.And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research.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 IgG4-related disease.
Detailed description
Immunoglobulin G4-related disease (IgG4-RD) is an immune-mediated fibroinflammatory condition that is capable of affecting multiple organs. Common forms of presentation include:Type 1 (IgG4-related) autoimmune pancreatitis (AIP)，IgG4-related sclerosing cholangitis, major salivary gland enlargement or sclerosing sialadenitis; Orbital disease, often with proptosis and retroperitoneal fibrosis. The involved organs share a number of core pathologic features and striking clinical and serologic similarities, including tumor-like swelling of involved organs, a lymphoplasmacytic infiltrate enriched in IgG4-positive plasma cells, and a variable degree of fibrosis that has a characteristic storiform pattern. 68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and it might be a pan-tumor PET agent. Recently we have reported a case of IgG4-related disease revealed by 68Ga-FAPI and 18F-FDG PET/CT which showed FAPI was not more tumor-specific than FDG, furthermore,it might be more sensitive than FDG in detecting a certain type of inflammations-like the pancreatic lesion. 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 IgG4-related disease.
Interventions
DRUG68Ga-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 IgG4-RD by PET/CT.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* suspected or confirmed untreated IgG4-RD 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic parameters | through study completion, an average of 1 year | Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value | 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 | through study completion, an average of 1 year | Number of participants and kind of adverse events as a measure of safety. |
| Disease burden assessement | 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 | through study completion, an average of 1 year | Correlation between FAPI expression and SUV in PET |
| Prediction value | through study completion, an average of 1 year | Prediction value of 68Ga-FAPI PET/CT for IgG4-RD in therapy response assessment |
Countries
China
Contacts
Primary ContactLi Huo, M.D.
Backup ContactYaping Luo, M.D.
Outcome results
None listed