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18F-FDG PET/CT for IgG4-Related Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Zhaohui Zhu, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01665196
First received: August 13, 2012
Last updated: November 1, 2014
Last verified: November 2014

August 13, 2012
November 1, 2014
October 2010
November 2015   (final data collection date for primary outcome measure)
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.
Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of organ involvement and treatment response of patients with IgG4-RD. [ 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 semiquantitative analysis will be performed by measuring the standardized uptake values (SUVs) of the involving regions. The response to anti-immune treatment will also be assessed.
Complete list of historical versions of study NCT01665196 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
18F-FDG PET/CT for IgG4-Related Disease
Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With 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.

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Autoimmune Disease
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
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.
Intervention: Drug: 18F-FDG
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 ¹⁸F-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 2016
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Hua Chen, MD 86-10-69158797 chen77hua@gmail.com
China
 
NCT01665196
IgG4RD-PET
Yes
Zhaohui Zhu, Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
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
Peking Union Medical College Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP