Back to results18F-FDG PET/CT for IgG4-Related Disease
Primary Purpose
Autoimmune Disease
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Autoimmune Disease focused on measuring IgG4-related disease, IgG4-RD, 18F-FDG, PET/CT
Eligibility Criteria
Inclusion Criteria:
- Males and females
- Age 18-75 years old with informed consent
Patients with IgG4-RD:
- swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
- elevated serum IgG4 (>1.35 g/L) or with histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
- exclusion of other diseases.
Exclusion Criteria:
- Females planning to bear a child recently or with childbearing potential;
- Inability to complete the examination;
- Concurrent severe and/or uncontrolled and/or unstable diseases;
- Currently under treatment using glucocorticoids.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FDG PET/CT scanning
Arm Description
18F-FDG PET/CT scanning will be performed in patients with IgG4RD to determine the pictorial characteristics and measure the standardized uptake values (SUVs) of the lesions and their response to treatment.
Outcomes
Primary Outcome Measures
Visual analysis of organ involvement and treatment response of the IgG4-RD patients.
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The 18F-FDG PET/CT pattern of IgG4-RG will be extracted and summarized. The response to anti-immune treatment will be assessed.
Secondary Outcome Measures
Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.
The semiquantitative analysis will be performed by measuring the standardized uptake values (SUVs) of 18F-FDG by the IgG4-RD lesions and calculate the SUV changes before and after anti-immune treatment.
Full Information
NCT ID
NCT01665196
First Posted
August 13, 2012
Last Updated
April 5, 2017
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01665196
Brief Title
18F-FDG PET/CT for IgG4-Related Disease
Official Title
Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT (positron emission tomography/computed tomography) in evaluation of patients with IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients with IgG4-related disease before and after treatment.
Detailed Description
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration. The most important feature of IgG4-RD is chronic inflammation with multiple organ involvement. However, some organ involvements are difficult to find by ultrasound, CT or MRI.
18F-FDG PET/CT is a sensitive imaging tool for inflammation. In this study, PET/CT were performed in patients with IgG4-RD both before and after glucocorticoid treatment by a single dose of 18F-FDG. Visual and semiquantitative method will be employed to assess the PET/CT images. The PET/CT image data will be used to establish a diagnostic model as well as assessment criteria for response evaluation of IgG4-RD treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disease
Keywords
IgG4-related disease, IgG4-RD, 18F-FDG, PET/CT
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
18F-FDG PET/CT scanning
Arm Type
Experimental
Arm Description
18F-FDG PET/CT scanning will be performed in patients with IgG4RD to determine the pictorial characteristics and measure the standardized uptake values (SUVs) of the lesions and their response to treatment.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
18F-Fluorodeoxyglucose, 2-Fluoro-2-deoxy-D-glucose, Fluorine-18-fluorodeoxyglucose
Intervention Description
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
Primary Outcome Measure Information:
Title
Visual analysis of organ involvement and treatment response of the IgG4-RD patients.
Description
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The 18F-FDG PET/CT pattern of IgG4-RG will be extracted and summarized. The response to anti-immune treatment will be assessed.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.
Description
The semiquantitative analysis will be performed by measuring the standardized uptake values (SUVs) of 18F-FDG by the IgG4-RD lesions and calculate the SUV changes before and after anti-immune treatment.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females
Age 18-75 years old with informed consent
Patients with IgG4-RD:
swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
elevated serum IgG4 (>1.35 g/L) or with histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
exclusion of other diseases.
Exclusion Criteria:
Females planning to bear a child recently or with childbearing potential;
Inability to complete the examination;
Concurrent severe and/or uncontrolled and/or unstable diseases;
Currently under treatment using glucocorticoids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Chen, MD
Phone
86-10-69158797
Email
chen77hua@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Organizational Affiliation
Deptment of Rheumatology, Peking Union Medical College Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fang Li, MD
Organizational Affiliation
Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Department of Nuclear Medicine, 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
Zhaohui Zhu, MD
Phone
86-10-69154196
Email
zhuzhh@pumch.cn
First Name & Middle Initial & Last Name & Degree
Hua Chen, MD
Phone
86-10-69158797
Email
chen77hua@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24764034
Citation
Zhang J, Chen H, Ma Y, Xiao Y, Niu N, Lin W, Wang X, Liang Z, Zhang F, Li F, Zhang W, Zhu Z. Characterizing IgG4-related disease with (1)(8)F-FDG PET/CT: a prospective cohort study. Eur J Nucl Med Mol Imaging. 2014 Aug;41(8):1624-34. doi: 10.1007/s00259-014-2729-3. Epub 2014 Apr 25.
Results Reference
derived
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18F-FDG PET/CT for IgG4-Related Disease
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