UMIN-CTR Clinical Trial

Basic information
Public title	A Study of Left Whole Breast Irradiation with Deep Inhalation Cardiac Dose Reduction Method Using Infrared Rangefinder
Acronym	A Study of Deep Inhalation Cardiac Dose Reduction Method Using Infrared Rangefinder
Scientific Title	A Study of Left Whole Breast Irradiation with Deep Inhalation Cardiac Dose Reduction Method Using Infrared Rangefinder
Scientific Title:Acronym	A Study of Left Whole Breast Irradiation with Deep Inhalation Cardiac Dose Reduction Method Using Infrared Rangefinder
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Partial mastectomy and postoperative whole breast irradiation are commonly performed for early-stage breast cancer. However, the heart is located on the dorsal side of the left breast, and if the heart is irradiated with a high dose, the incidence of cardiovascular disorders increases as a late adverse event. Normally, radiation therapy is administered under free-breathing conditions, but irradiation during inspiration only can reduce the cardiac dose because the distance between the breast and the heart is greater than under free-breathing conditions. While insufflation irradiation can reduce the cardiac dose, since insufflation is stopped and irradiation is performed multiple times in one irradiation, reproducibility of the insufflation breath-hold state (position of the rib cage and heart) each time is important. If the reproducibility of the inhalation volume is low, the dose to the irradiation target volume and the cardiac dose reduction effect will be reduced, and various methods have been tried to confirm the reproducibility of the inhalation in this irradiation method. In this study, we prepared a relatively inexpensive device for confirming respiratory reproducibility by using an infrared rangefinder, and aim to ensure reproducibility during deep inspiration during left breast irradiation using this method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Inhalation reproducibility when irradiated during inhalation using an infrared distance meter
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Irradiate during inhalation using an infrared distance meter.
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	Female
Key inclusion criteria	The patient had a partial left mastectomy and was undergoing whole breast irradiation. The patient has a left nipple (not after papillotomy). The patient is between 20 and 60 years old at the time of the first visit to our department. ECOG PS is 0 or 1. The patient can hold his/her breath for more than 20 seconds.
Key exclusion criteria	Pain prevents the patient from maintaining external rest for 10 minutes. Has a history of active collagen disease. She is pregnant. Has a postoperative pacemaker.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Naoto Middle name Ohshima Last name Shikama
Organization	Juntendo university
Division name	Department of Radiation Oncology
Zip code	1130033
Address	Bunkyo Hongo 3-1-1
TEL	0338133111
Email	n-shikama@juntendo.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Ohshima Last name Oshima
Organization	Juntendo university
Division name	Department of Radiation Oncology
Zip code	1130033
Address	Bunkyo Hongo 3-1-1
TEL	0338133111
Homepage URL
Email	msoosima@juntendo.ac.jp

Sponsor
Institute	Juntendo university
Institute
Department

Funding Source
Organization	Juntendo university
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	Juntendo University
Address	Tokyo Bunkyo Hongo 3-1-1
Tel	09055104845
Email	msoosima@juntendo.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	2021 Year 01 Month 04 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 01 Day
Date of IRB	2020 Year 12 Month 01 Day
Anticipated trial start date	2020 Year 12 Month 22 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 03 Day
Last modified on	2021 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048879

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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