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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04125511

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IgG4-related Disease	Drug: 68Ga-FAPI	Early Phase 1

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

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-FAPI, PET/CT Inject 68Ga-FAPI and then perform PET/CT scan.	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. Other Names: 68Ga-fibroblast activating protein inhibitors

Arm

Intervention/Treatment

Experimental: 68Ga-FAPI, PET/CT

Inject 68Ga-FAPI and then perform PET/CT scan.

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.

Other Names:

68Ga-fibroblast activating protein inhibitors

Outcome Measures

Primary Outcome Measures

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

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator: Li Huo, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT04125511

Other Study ID Numbers:

PekingUMCHFAPI

First Posted:

Oct 14, 2019

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Immunoglobulin G4-Related Disease

Study Results

No Results Posted as of Jan 26, 2021