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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044113
Receipt No. R000050371
Scientific Title Usefulness of Diffusion-Weighted Whole-Body Imaging with Background Body Signal Suppression (DWIBS) Method for Imaging Evaluation of Large-Scale Vasculitis
Date of disclosure of the study information 2021/12/01
Last modified on 2021/05/05

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Basic information
Public title Usefulness of Diffusion-Weighted Whole-Body Imaging with Background Body Signal Suppression (DWIBS) Method for Imaging Evaluation of Large-Scale Vasculitis
Acronym Usefulness of Diffusion-Weighted Whole-Body Imaging with Background Body Signal Suppression (DWIBS) Method for Imaging Evaluation of Large-Scale Vasculitis
Scientific Title Usefulness of Diffusion-Weighted Whole-Body Imaging with Background Body Signal Suppression (DWIBS) Method for Imaging Evaluation of Large-Scale Vasculitis
Scientific Title:Acronym Usefulness of Diffusion-Weighted Whole-Body Imaging with Background Body Signal Suppression (DWIBS) Method for Imaging Evaluation of Large-Scale Vasculitis
Region
Japan

Condition
Condition Large Vessels Artritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In recent years, FDG-PET/CT has been approved for the evaluation of disease activity in large vessel vasculitis, and FDG-PET/CT examinations have been performed mainly at university hospitals. In recent years, however, FDG-PET/CT has been approved for the evaluation of disease activity in large vasculitis, and FDG-PET/CT is now being performed mainly in university hospitals. However, it has not been widely used due to the lack of facilities and medical costs. In this prospective study, we evaluated the sensitivity and specificity of FDG-PET/CT and DWIBS using MRI (DWIBS), which is less expensive than FDG-PET/CT and does not involve radiation exposure, in 40 patients with large vessel vasculitis to determine the usefulness of DWIBS for evaluating the activity of large vessel vasculitis in the future. The results of this study will be presented.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between FDG-PET/CT diagnosis and qualitative evaluation of DWIBS. The sensitivity, specificity, and positive/negative predictive value of DWIBS were determined for each of the four grades: grade 0 or higher, grade 1 or higher, grade 2 or higher, and grade 3 or higher.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients diagnosed with large vessel vasculitis (Takayasu disease criteria 2, giant cell arteritis 3 classification criteria) in our department (new cases and cases under treatment)
Key exclusion criteria 1) Severe diabetes mellitus
2) Claustrophobia
3) Patients with metal implants in the body (metal clips in the brain, artificial heart valves, stents)
4) Patients with nail art, tattoos, etc.
5) Patients under 15 years old
6) Cases where patient consent cannot be obtained
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Nozaki
Organization Kindai University School of Medicine
Division name Department of Hematology and Rheumatology
Zip code 589-8511
Address Osaka-Sayama
TEL 0723660221
Email yuji0516@med.kindai.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name Nozaki
Last name Nozaki
Organization Kinki University School of Medicine
Division name Department of Hematology and Rheumatology
Zip code 589-8511
Address Osaka-Sayama
TEL 0723660221
Homepage URL
Email yuji0516@med.kindai.ac.jp

Sponsor
Institute Kinki University School of Medicine
Institute
Department

Funding Source
Organization Kinki University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Hematology and Rheumatology, Kinki University School of Medicine
Address 377-2 Ohno-Higashi
Tel 0723660221
Email yuji0516@med.kindai.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2026 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective observational study. FDG-PET/CT and DWIBS will be performed within 4 weeks of the blood test in addition to the blood tests regularly evaluated in the outpatient clinic. FDG-PET/CT and DWIBS will be performed at 24 weeks after the start of treatment to confirm the efficacy of treatment in new patients without prior treatment, although this is not mandatory.
Blood tests include CRP, ESR, IL-6, white blood cell count, Hb, and platelet count, and vasculitis symptoms are evaluated by examination and interview.


Management information
Registered date
2021 Year 05 Month 05 Day
Last modified on
2021 Year 05 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050371

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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