18F-FDG PET/CT for IgG4-Related Disease
This study is currently recruiting participants.
Verified February 2013 by Peking Union Medical College Hospital
Sponsor:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Zhaohui Zhu, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01665196
First received: August 13, 2012
Last updated: February 26, 2013
Last verified: February 2013
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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:
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 2014 |
| Estimated Primary Completion Date: | January 2014 (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:
|
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:
- 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;
- 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);
- 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
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 zzh_1969@yahoo.com.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
| 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: | February 26, 2013 |
| 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 Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013