Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2012-09-30
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
18F-FDG
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
Interventions
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18F-FDG
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-75 years old with informed consent
* Patients with IgG4-RD:
1. 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;
2. 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);
3. exclusion of other diseases.
Exclusion Criteria
* Inability to complete the examination;
* Concurrent severe and/or uncontrolled and/or unstable diseases;
* Currently under treatment using glucocorticoids.
18 Years
75 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Zhaohui Zhu
Professor
Principal Investigators
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Wen Zhang, MD
Role: STUDY_DIRECTOR
Deptment of Rheumatology, Peking Union Medical College Hospital
Fang Li, MD
Role: STUDY_CHAIR
Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC
Zhaohui Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nuclear Medicine, Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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IgG4RD-PET
Identifier Type: -
Identifier Source: org_study_id
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