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

Autoimmune Disease Clinical Trial

Official title:

Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01665196
• Other study ID #: IgG4RD-PET
• Status: Recruiting
• Phase: Early Phase 1
• First received: August 13, 2012
• Last updated: April 5, 2017
• Start date: September 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: Hua Chen, MD
• Phone: 86-10-69158797
• Email: chen77hua[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases

Intervention

Drug:
• 18F-FDG
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analysis of organ involvement and treatment response of the IgG4-RD patients.	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.	1 year
Secondary	Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.	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.	1 year