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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01665196

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

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 :

Sep 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Primary Outcome Measures

Visual analysis of organ involvement and treatment response of the IgG4-RD patients. [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

Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients. [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

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

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