Characterizing IgG4-RD With 68Ga-FAPI PET/CT
Characterizing IgG4-related Disease With 68Ga-FAPI PET/CT
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 14, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJanuary 26, 2021
January 1, 2021
1.9 years
August 28, 2019
January 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 (5)
Diagnostic value
through study completion, an average of 1 year
adverse events
through study completion, an average of 1 year
Disease burden assessement
through study completion, an average of 1 year
FAPI expression and SUV
through study completion, an average of 1 year
Prediction value
through study completion, an average of 1 year
Study Arms (1)
68Ga-FAPI, PET/CT
EXPERIMENTALInject 68Ga-FAPI and then perform PET/CT scan.
Interventions
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.
Eligibility Criteria
You may qualify if:
- suspected or confirmed untreated IgG4-RD patients;
- F-FDG PET/CT within two weeks;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Huo, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2019
First Posted
October 14, 2019
Study Start
November 1, 2019
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share