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

IgG4-related Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04125511
• Other study ID #: PekingUMCHFAPI
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2021
• Source: Peking Union Medical College Hospital
• Contact: Li Huo, M.D.
• Phone: 86-10-69155537
• Email: huoli[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• IgG4-related Disease

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic parameters	Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT.	through study completion, an average of 1 year
Secondary	Diagnostic value	Diagnostic value of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT.	through study completion, an average of 1 year
Secondary	adverse events	Number of participants and kind of adverse events as a measure of safety.	through study completion, an average of 1 year
Secondary	Disease burden assessement	Correlation between disease burden assessed on 68Ga-FAPI PET/CT and clinical parameters for IgG4-RD.	through study completion, an average of 1 year
Secondary	FAPI expression and SUV	Correlation between FAPI expression and SUV in PET	through study completion, an average of 1 year
Secondary	Prediction value	Prediction value of 68Ga-FAPI PET/CT for IgG4-RD in therapy response assessment	through study completion, an average of 1 year