NCT04125511

Characterizing IgG4-RD With 68Ga-FAPI PET/CT

Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IgG4-related Disease

Interventions

Type	Name	Description
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 IgG4-RD by PET/CT.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2019-10-14
• Last updated: 2021-01-26

Locations

1 site across 1 country: China