UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051218 |
|---|---|
| Receipt number | R000058355 |
| Scientific Title | A volunteer's study for evaluation of MR images for MR image-guided radiotherapy |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2023/06/01 09:52:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A volunteer's study for evaluation of MR images for MR image-guided radiotherapy
Acronym
A volunteer's study for evaluation of MR images for MR image-guided radiotherapy
Scientific Title
A volunteer's study for evaluation of MR images for MR image-guided radiotherapy
Scientific Title:Acronym
A volunteer's study for evaluation of MR images for MR image-guided radiotherapy
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Technical Validation of MR Image-Guided Radiotherapy with MR-Linac
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical Validation of MR Image-Guided Radiotherapy with MR-Linac
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the Elekta MR-Linac, uncontrast-enhanced MR images were taken in healthy volunteers for research purposes, and image quality evaluation and organ movement analysis were performed.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy person
(2) disease stage, stage: none
(3) Age 20 to 60 (at the time of registration)
(4) Gender: Any
(5) Subjects who have given their written consent to participate in research
Key exclusion criteria
1. Claustrophobia
2. Those who have metal in their body
3. Those who do not agree to participate in research
4. Persons (students, graduate students, staff, etc.) belonging to the field of research director and research co-investigator (including the field of concurrent work)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kadoya |
Organization
Tohoku University
Division name
Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7433
noriyuki.kadoya.e4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kadoya |
Organization
Tohoku University
Division name
Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7433
Homepage URL
noriyuki.kadoya.e4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
Tel
022-717-7433
noriyuki.kadoya.e4@tohoku.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 | 06 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058355
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
