18F-FDG PET/CT for IgG4-Related Disease
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|ClinicalTrials.gov Identifier: NCT01665196|
Recruitment Status : Recruiting
First Posted : August 15, 2012
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Disease||Drug: 18F-FDG||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
- Visual analysis of organ involvement and treatment response of the IgG4-RD patients. [ Time Frame: 1 year ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665196
|Contact: Hua Chen, MDemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD 86-10-69154196 firstname.lastname@example.org|
|Contact: Hua Chen, MD 86-10-69158797 email@example.com|
|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|