NCT01665196

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

5.3 years

First QC Date

August 13, 2012

Last Update Submit

April 5, 2017

Conditions

Autoimmune Disease

Keywords

IgG4-related diseaseIgG4-RD18F-FDGPET/CT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.

    1 year

Study Arms (1)

18F-FDG PET/CT scanning

EXPERIMENTAL

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.

Drug: 18F-FDG

Interventions

18F-FDGDRUG

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

Also known as: 18F-Fluorodeoxyglucose, 2-Fluoro-2-deoxy-D-glucose, Fluorine-18-fluorodeoxyglucose
18F-FDG PET/CT scanning

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • Age 18-75 years old with informed consent
  • Patients with IgG4-RD:
  • 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;
  • 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);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24764034DERIVED

MeSH Terms

Conditions

Autoimmune DiseasesImmunoglobulin G4-Related Disease

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Wen Zhang, MD

    Deptment of Rheumatology, Peking Union Medical College Hospital

    STUDY DIRECTOR

  • Fang Li, MD

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

    STUDY CHAIR

  • Zhaohui Zhu, MD

    Department of Nuclear Medicine, Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Chen, MD

CONTACT

86-10-69158797chen77hua@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 15, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)