UMIN-CTR Clinical Trial

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
Email	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
Email	jtanaka@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031596