UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035947 |
|---|---|
| Receipt number | R000040940 |
| Scientific Title | The influence of cavity volumetric changes investigated by MRI on the dose distribution over the APBI therapy |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2019/02/20 10:47:09 |
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Basic information
Public title
The influence of cavity volumetric changes investigated by MRI on the dose distribution over the APBI therapy
Acronym
The influence of cavity changes on the dose distribution over the APBI therapy
Scientific Title
The influence of cavity volumetric changes investigated by MRI on the dose distribution over the APBI therapy
Scientific Title:Acronym
The influence of cavity changes on the dose distribution over the APBI therapy
Region
| Japan |
Condition
Condition
breast cancers
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
MRI examinations were conducted to investigate each cavity change which would give an influence on the dose distribution of Accelerated Partial Breast Irradiation (APBI) over the postoperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
On the postoperative day1 and day3, (MRI1) (MRI2) were performed. These MRIbased plans were reconstructed to measure the dosimetric parameters such as V90, V150 and max doses against the skin and the chest wall. These dosimetric factors were the primary evaluation items in this study
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
Female
Key inclusion criteria
The key inclusion criteria was that APBI therapy was accomplished and on top of that in the postoperative period, MRI examinations were performed twice to obtain mri images.
Key exclusion criteria
The key exclusion criteria was that in the postoperative period, MRI examinations were not performed twice to obtain MRI images.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kato |
Organization
Tokyo nishi tokushuukai hospital
Division name
radiation medical center
Zip code
Address
Akishima-city 3-1-1 Tokyo
TEL
042-500-4433
raijinnpower@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Kato |
Organization
Tokyo nishi tokushuukai hospital
Division name
radiation medical center
Zip code
Address
Akishima-city 3-1-1 Tokyo
TEL
042-500-4433
Homepage URL
raijinnpower@yahoo.co.jp
Sponsor or person
Institute
Tokyo nishi tokushuukai hospital
Institute
Department
Personal name
Funding Source
Organization
Self-pay burden
Organization
Division
Category of Funding Organization
Self funding
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
| 2020 | Year | 01 | Month | 10 | 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
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
As for MRI1/MRI2, the mean volume (ml) of V90, V150, were 46.09/44.3, 15.13/14.2, respectively. The Max doses against the skin and chest wall (cGy) were 245.4/242.9 and 262.4/248.9 respectively.No significant differences were detected at all.
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040940
