18F-FDG PET/CT for IgG4-Related Disease
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease|
- Visual analysis of organ involvement and treatment response of the IgG4-RD patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: 18F-FDG PET/CT scanning
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.
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665196
|Contact: Hua Chen, MDfirstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD 86-10-69154196 email@example.com|
|Contact: Hua Chen, MD 86-10-69158797 firstname.lastname@example.org|
|Study Director:||Wen Zhang, MD||Deptment of Rheumatology, Peking Union Medical College Hospital|
|Study Chair:||Fang Li, MD||Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC|
|Principal Investigator:||Zhaohui Zhu, MD||Department of Nuclear Medicine, Peking Union Medical College Hospital|