UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042888 |
|---|---|
| Receipt number | R000048879 |
| Scientific Title | A Study of Left Whole Breast Irradiation with Deep Inhalation Cardiac Dose Reduction Method Using Infrared Rangefinder |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2021/12/09 11:25:05 |
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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
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
msoosima@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
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
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
22
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
| 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
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048879
