Autoimmune DiseaseEarly Phase 1NCT01665196
18F-FDG PET/CT for IgG4-Related Disease
A Early Phase 1 study testing 18F-FDG in people with Autoimmune Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Disease
- What is being tested?
- 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- exclusion of other diseases.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, 86-10-69154196, zhuzhh@pumch.cn
Hua Chen, MD, 86-10-69158797, chen77hua@gmail.com
About this study
Official title: Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease
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.
Read the 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.
- Conditions
- Autoimmune Disease
- Being tested
- 18F-FDG
- Keywords
- IgG4-related disease, IgG4-RD, 18F-FDG, PET/CT
- Medical subject headings
- Autoimmune Diseases, Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
Also called 18F-Fluorodeoxyglucose, 2-Fluoro-2-deoxy-D-glucose, Fluorine-18-fluorodeoxyglucose
Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Zhu, Peking Union Medical College Hospital
- Investigators
- Wen Zhang, MD, Study director, Deptment of Rheumatology, Peking Union Medical College HospitalFang Li, MD, Study chair, Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMCZhaohui Zhu, MD, Principal investigator, Department of Nuclear Medicine, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665196
- Sponsor's protocol ID
- IgG4RD-PET
- Status last verified
- Apr 2017
- First submitted
- 13 Aug 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24764034
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease
- ClinicalTrials.gov ID
- NCT01665196
- Acronym / sponsor ID
- IgG4RD-PET
- Conditions
- Autoimmune Disease
- Keywords
- IgG4-related disease, IgG4-RD, 18F-FDG, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET/CT scanning | Experimental | Drug: 18F-FDG18F-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females
- Age 18-75 years old with informed consent
- Patients with IgG4-RD:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDGAlso: 18F-Fluorodeoxyglucose, 2-Fluoro-2-deoxy-D-glucose, Fluorine-18-fluorodeoxyglucoseIntravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively. | Drug | 18F-FDG PET/CT scanning |
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.
1 secondary outcome
Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 24764034Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Zhang, MD study director
Deptment of Rheumatology, Peking Union Medical College Hospital
Fang Li, MD study chair
Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC
Zhaohui Zhu, MD principal investigator
Department of Nuclear Medicine, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDG in people with Autoimmune Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Chen, MD (86-10-69158797, chen77hua@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analysis of organ involvement and treatment response of the IgG4-RD patients. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.