UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027584 |
|---|---|
| Receipt number | R000031596 |
| Scientific Title | Evaluation of a new X-ray imaging system based on Talbot-Lau interferometry: initial images of healthy volunteers and patients (Development of a new X-ray diagnostic modality) |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2020/12/09 09:45:02 |
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Basic information
Public title
Evaluation of a new X-ray imaging system based on Talbot-Lau interferometry: initial images of healthy volunteers and patients (Development of a new X-ray diagnostic modality)
Acronym
Evaluation of a new X-ray imaging system based on Talbot-Lau interferometry: initial images of healthy volunteers and patients
Scientific Title
Evaluation of a new X-ray imaging system based on Talbot-Lau interferometry: initial images of healthy volunteers and patients (Development of a new X-ray diagnostic modality)
Scientific Title:Acronym
Evaluation of a new X-ray imaging system based on Talbot-Lau interferometry: initial images of healthy volunteers and patients
Region
| Japan |
Condition
Condition
Bone and joint disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of an new X-ray imaging technology based on X-ray interferometry
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the efficacy of an new X-ray imaging technology based on X-ray interferometry, especially for early diagnosis of rheumatoid arthritis and minimal trauma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
X-ray imaging
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
Normal volunteers and patients of early rheumatoid arthritis and probable joint diseases
Key exclusion criteria
those under 18 years old, and those who cannot understand the meaning of this trial
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Tanaka |
Organization
Saitama medical university hospital
Division name
Department of radiology
Zip code
Address
38 Morohongo Moroyamamachi Iruma-gun Saitama Japan
TEL
049-276-1265
jtanaka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Tanaka |
Organization
Saitama medical university hospital
Division name
Department of radiology
Zip code
Address
38 Morohongo Moroyamamachi Iruma-gun Saitama Japan
TEL
049-276-1265
Homepage URL
jtanaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Department of radiology, Saitama medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1038/s41598-020-63155-9
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
| 2012 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031596
