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

NCT ID: NCT01665196

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmune Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

18F-FDG

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-FDG

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-Fluorodeoxyglucose 2-Fluoro-2-deoxy-D-glucose Fluorine-18-fluorodeoxyglucose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhaohui Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wen Zhang, MD

Role: STUDY_DIRECTOR

Deptment of Rheumatology, Peking Union Medical College Hospital

Fang Li, MD

Role: STUDY_CHAIR

Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC

Zhaohui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nuclear Medicine, Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hua Chen, MD

Role: CONTACT

86-10-69158797

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhaohui Zhu, MD

Role: primary

86-10-69154196

Hua Chen, MD

Role: backup

86-10-69158797

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24764034 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IgG4RD-PET

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

99mTc-CNDG SPECT/CT in Brain Tumors
NCT06362304 RECRUITING NA
ImmunoPET With an Anti-CD8 Imaging Agent
NCT04029181 ACTIVE_NOT_RECRUITING PHASE1/PHASE2