Clinical Trial: 18F-FDG PET/CT for IgG4-Related Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Visual analysis of organ involvement and treatment response of the IgG4-RD patients. [ Time Frame: 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.


Original Primary Outcome: Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of organ involvement and treatment response of patients with IgG4-RD. [ Time Frame: 1 year ]

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.


Current Secondary Outcome: Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients. [ Time Frame: 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.


Original Secondary Outcome:

Information By: Peking Union Medical College Hospital

Dates:
Date Received: August 13, 2012
Date Started: September 2012
Date Completion: December 2017
Last Updated: April 5, 2017
Last Verified: April 2017