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Clinical Trials/NCT04125511
NCT04125511UnknownEarly Phase 1

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

Peking Union Medical College Hospital1 site in 1 country100 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions
Drugs

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

Experimental

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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