UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022765 |
|---|---|
| Receipt number | R000026228 |
| Scientific Title | A study aiming to improve the dosimetric accuracy of spot-scanning proton therapy |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2023/01/06 07:52:24 |
* 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 study aiming to improve the dosimetric accuracy of spot-scanning proton therapy
Acronym
A study aiming to improve the dosimetric accuracy of spot-scanning proton therapy
Scientific Title
A study aiming to improve the dosimetric accuracy of spot-scanning proton therapy
Scientific Title:Acronym
A study aiming to improve the dosimetric accuracy of spot-scanning proton therapy
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main aim of this study is to improve the dosimetric accuracy and efficiency of the current spot-scanning and beam-gating techniques in proton therapy by developing a new calculation algorithms, a new biological dose evaluation system, and new beam-shaping devices.
Basic objectives2
Others
Basic objectives -Others
The aim of this study includes the development of a new calculation algorithm which enables more accurate evaluation of dose distribution in patients, a new biological dose evaluation system which derives the biological equivalent dose distributions over the treatment course, as well as new beam-shaping devices which enable us to make more conformal and uniform dose distributions in tumours.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proton dose distributions and some dosimetric indices representing the quality of the distributions (e.g. maximum/ minimum dose, average dose)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The outpatients or inpatients in Department of Radiation Oncology, Hokkaido University Hospital treated with radiation therapy from March 17, 2014 to January 31, 2016.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Shirato |
Organization
Hokkaido University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5977
shirato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Shirato |
Organization
Hokkaido University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5977
Homepage URL
shirato@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2016 | Year | 06 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory studies using existing information.
Management information
Registered date
| 2016 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026228
