UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044113
Receipt number 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 2022/11/07 09:57:01

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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 or person

Institute

Kinki University School of Medicine

Institute

Department

Personal name



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

Open public recruiting

Date of protocol fixation

2021 Year 04 Month 20 Day

Date of IRB

2021 Year 06 Month 10 Day

Anticipated trial start date

2021 Year 06 Month 10 Day

Last follow-up date

2026 Year 06 Month 10 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

2022 Year 11 Month 07 Day



Link to view the page

Value
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