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

Early Phase 1

• Conditions: IgG4-related Disease
• Interventions: Drug: 68Ga-FAPI

• Registration Number: NCT04125511
• Lead Sponsor: Peking Union Medical College Hospital

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 Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-11-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI, PET/CT	68Ga-FAPI	Inject 68Ga-FAPI and then perform PET/CT scan.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China