Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT
Trial Snapshot
- Phase
- Early Phase 1
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Metabolic parameters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
68Ga-FAPI, PET/CT
Inject 68Ga-FAPI and then perform PET/CT scan.
Intervention: 68Ga-FAPI (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Disease burden assessement(through study completion, an average of 1 year)
- FAPI expression and SUV(through study completion, an average of 1 year)
- Prediction value(through study completion, an average of 1 year)
- Diagnostic value(through study completion, an average of 1 year)
- adverse events(through study completion, an average of 1 year)