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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
Sponsor:
Information provided by (Responsible Party):
Zhaohui Zhu, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autoimmune Disease Drug: 18F-FDG Early Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 18F-FDG
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
Other Names:
  • 18F-Fluorodeoxyglucose
  • 2-Fluoro-2-deoxy-D-glucose
  • Fluorine-18-fluorodeoxyglucose


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females
  • 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:

  • 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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Hua Chen, MD 86-10-69158797 chen77hua@gmail.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, MD    86-10-69154196    zhuzhh@pumch.cn   
Contact: Hua Chen, MD    86-10-69158797    chen77hua@gmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Zhaohui Zhu, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01665196     History of Changes
Other Study ID Numbers: IgG4RD-PET
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhaohui Zhu, Peking Union Medical College Hospital:
IgG4-related disease
IgG4-RD
18F-FDG
PET/CT

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Fluorodeoxyglucose F18
Immunoglobulin G
 Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs