UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of cavity volumetric changes investigated by MRI on the dose distribution over the APBI therapy
Title of the study (Brief title)	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	Masahiro Kato
Organization	Tokyo nishi tokushuukai hospital
Division name	radiation medical center
Address	Akishima-city 3-1-1 Tokyo
TEL	042-500-4433
Email	raijinnpower@yahoo.co.jp

Public contact
Name of contact person	Masahiro Kato
Organization	Tokyo nishi tokushuukai hospital
Division name	radiation medical center
Address	Akishima-city 3-1-1 Tokyo
TEL	042-500-4433
Homepage URL
Email	raijinnpower@yahoo.co.jp

Sponsor
Institute	Tokyo nishi tokushuukai hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040940