Characterizing IgG4-RD With 68Ga-FAPI PET/CT | NCT04125511

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

NCT04125511

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2021Actual

Enrollment

100Estimated

Phase

Early Phase 1

Conditions

IgG4-related Disease

Interventions

68Ga-FAPI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Oct 1, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Aug 28, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
68Ga-FAPI, PET/CT	Experimental	Inject 68Ga-FAPI and then perform PET/CT scan.	Drug: 68Ga-FAPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-FAPI	Drug	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.	68Ga-FAPI, PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
adverse events	Number of participants and kind of adverse events as a measure of safety.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li Huo, M.D.	Contact	86-10-69155537		huoli@pumch.cn
Yaping Luo, M.D.	Contact	86-10-69157033		luoyaping@live.com

Overall Officials

Name	Affiliation	Role
Li Huo, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42129009	Derived	Liu S, Pan Q, Zhang H, Peng L, Zhang W, Feng Y, Luo Y. [68Ga]Ga-FAPI-04 PET/CT for subtyping and prognostication of IgG4-related disease. EJNMMI Res. 2026 May 13. doi: 10.1186/s13550-026-01451-7. Online ahead of print.

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases