Clinical trial NCT04125511: Characterizing IgG4-RD With 68Ga-FAPI PET/CT
Official title: Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: IgG4-related Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Metabolic parameters
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1 year
measure: adverse events
timeFrame: through study completion, an average of 1 year
measure: Disease burden assessement
timeFrame: through study completion, an average of 1 year
measure: FAPI expression and SUV
timeFrame: through study completion, an average of 1 year
measure: Prediction value
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Huo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: