UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052239 |
|---|---|
| Receipt number | R000055581 |
| Scientific Title | Impact of diffusion-weighted whole-body imaging with background signal suppression on diagnostic performance for fever or inflammation of unknown origin: a Multi-center Prospective Cohort Study. |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2025/03/20 16:37:40 |
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Basic information
Public title
Impact of diffusion-weighted whole-body imaging with background signal suppression on diagnostic performance for fever or inflammation of unknown origin: a Multi-center Prospective Cohort Study.
Acronym
Impact of DWIBS performance for FUO or IUO
Scientific Title
Impact of diffusion-weighted whole-body imaging with background signal suppression on diagnostic performance for fever or inflammation of unknown origin: a Multi-center Prospective Cohort Study.
Scientific Title:Acronym
Impact of DWIBS performance for FUO or IUO
Region
| Japan |
Condition
Condition
Fever of unknown origin, inflammation of unknown origin
Classification by specialty
| Medicine in general | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of diffusion-weighted whole-body imaging with background signal suppression (DWIBS) for fever of unknown origin (FUO) and inflammation of unknown origin (IUO).
Basic objectives2
Others
Basic objectives -Others
To evaluate the diagnostic and prognostic performance of diffusion-weighted whole body imaging with background body signal suppression (DWIBS) in patients with fever of unknown origin (FUO) and inflammation of unknown origin (IUO).
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Description of additional tests, final diagnosis, clinical course, and outcome after testing in patients who are positive or negative for diffusion-weighted whole body imaging with background body signal suppression (DWIBS)
Key secondary outcomes
Comparison of diagnostic performance with other imaging tests
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a body temperature of 37.5 degrees or higher or CRP of 0.4 mg/dL or higher, for whom the cause of fever or inflammation cannot be determined by history taking, medical examination, or routine examination, and who have undergone CT (with or without contrast), gallium scintigraphy, or PET-CT imaging, and who have given consent
Key exclusion criteria
Patients who cannot give consent
Patients for whom MRI is inappropriate (presence of metal in the body, claustrophobia, tattoos)
Pregnant women, patients with impaired consciousness, patients in shock
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keishiro |
| Middle name | |
| Last name | Sueda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of General Medicine
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya Ku, Saitama city, Saitama
TEL
048-647-2111
k.sueda@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Keishiro |
| Middle name | |
| Last name | Sueda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of General Medicine
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya Ku, Saitama city, Saitama
TEL
048-647-2111
Homepage URL
k.sueda@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama Central Clinic, Kyosai Hospital, Saitama Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical Center, Jichi Medical University
Address
1-847, Amanuma-cho, Omiya Ku, Saitama city, Saitama
Tel
048-647-2111
s-suishin@jichi.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
| 2023 | Year | 09 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
We did a multi-centre, prospective observational study to assessed the efficacy of Diffusion-weighted whole-body imaging with background body signal suppression (DWIBS) for fever of unknown origin (FUO) and inflammation of unknown origin (IUO). This study will be conducted in Saitama Medical Center, Jichi Medical University from 1 September 2022 to 31 March 2027. The study will be conducted and reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology Statement.
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055581
