Characterizing IgG4-RD With 68Ga-FAPI PET/CT
Primary Purpose
IgG4-related Disease
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
About this trial
This is an interventional diagnostic trial for IgG4-related Disease
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI, PET/CT
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan.
Outcomes
Primary Outcome Measures
Metabolic parameters
Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT.
Secondary Outcome Measures
Diagnostic value
Diagnostic value of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT.
adverse events
Number of participants and kind of adverse events as a measure of safety.
Disease burden assessement
Correlation between disease burden assessed on 68Ga-FAPI PET/CT and clinical parameters for IgG4-RD.
FAPI expression and SUV
Correlation between FAPI expression and SUV in PET
Prediction value
Prediction value of 68Ga-FAPI PET/CT for IgG4-RD in therapy response assessment
Full Information
NCT ID
NCT04125511
First Posted
August 28, 2019
Last Updated
January 24, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04125511
Brief Title
Characterizing IgG4-RD With 68Ga-FAPI PET/CT
Official Title
Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4-related Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI, PET/CT
Arm Type
Experimental
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic parameters
Description
Total Lesion Glycolysis (TLG) of focal lesions are measured on 68Ga-FAPI PET/CT.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Diagnostic value
Description
Diagnostic value of 68Ga-FAPI PET/CT for IgG4-RD in comparison with 18F-FDG PET/CT.
Time Frame
through study completion, an average of 1 year
Title
adverse events
Description
Number of participants and kind of adverse events as a measure of safety.
Time Frame
through study completion, an average of 1 year
Title
Disease burden assessement
Description
Correlation between disease burden assessed on 68Ga-FAPI PET/CT and clinical parameters for IgG4-RD.
Time Frame
through study completion, an average of 1 year
Title
FAPI expression and SUV
Description
Correlation between FAPI expression and SUV in PET
Time Frame
through study completion, an average of 1 year
Title
Prediction value
Description
Prediction value of 68Ga-FAPI PET/CT for IgG4-RD in therapy response assessment
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, M.D.
Phone
86-10-69155537
Email
huoli@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Luo, M.D.
Phone
86-10-69157033
Email
luoyaping@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Huo, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD
Email
Huoli@pumch.cn
First Name & Middle Initial & Last Name & Degree
Yaping Luo, MD
Email
luoyaping@live.com
First Name & Middle Initial & Last Name & Degree
Li Huo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Characterizing IgG4-RD With 68Ga-FAPI PET/CT
We'll reach out to this number within 24 hrs