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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
History of Changes
  Purpose

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 Intervention Phase
Autoimmune Disease
 Drug: 18F-FDG
 Phase 0

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Estimated Enrollment: 30
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)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Peking Union Medical College Hospital

Additional 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
Study First Received: August 13, 2012
Last Updated: November 1, 2014
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Deoxyglucose
Fluorodeoxyglucose F18
Anti-Infective Agents
Antimetabolites
 Antiviral Agents
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015