Clinical trial NCT01665196: 18F-FDG PET/CT for IgG4-Related Disease
Official title: Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Autoimmune Disease
Keywords: IgG4-related disease
IgG4-RD
18F-FDG
PET/CT
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 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.

Primary outcomes:
measure: Visual analysis of organ involvement and treatment response of the IgG4-RD patients.
timeFrame: 1 year
Secondary outcomes:
measure: Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
name: Wen Zhang, MD
role: STUDY_DIRECTOR
affiliation: Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC
name: Fang Li, MD
role: STUDY_CHAIR
affiliation: Department of Nuclear Medicine, Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Chen H, Ma Y, Xiao Y, Niu N, Lin W, Wang X, Liang Z, Zhang F, Li F, Zhang W, Zhu Z. Characterizing IgG4-related disease with (1)(8)F-FDG PET/CT: a prospective cohort study. Eur J Nucl Med Mol Imaging. 2014 Aug;41(8):1624-34. doi: 10.1007/s00259-014-2729-3. Epub 2014 Apr 25.