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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Deoxyglucose; Fluorodeoxyglucose F18; Immunoglobulin G

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.