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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030255
Receipt No. R000034490
Scientific Title MR-guided Focused Ultrasound Surgery of ductal carcinoma in situ: Therapeutic effect and safety
Date of disclosure of the study information 2017/12/11
Last modified on 2018/12/20

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Basic information
Public title MR-guided Focused Ultrasound Surgery of ductal carcinoma in situ: Therapeutic effect and safety
Acronym MR-guided Focused Ultrasound Surgery of ductal carcinoma in situ: Therapeutic effect and safety
Scientific Title MR-guided Focused Ultrasound Surgery of ductal carcinoma in situ: Therapeutic effect and safety
Scientific Title:Acronym MR-guided Focused Ultrasound Surgery of ductal carcinoma in situ: Therapeutic effect and safety
Region
Japan

Condition
Condition Ductal carcinoma in situ
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 MRI guided focused ultrasound (MRgFUS) is completly noninvasaive treatment that generates protein denaturation in the target lesion by focusing ultrasound onto the target tissue.
In this study, we verify complete abaltion of cancer cell in ductal carcinoma in situ (DCIS).
If efficacy and safety of this treatment on breast cancer can be verified with this study, this may be a step forward for further expansion of indication and non-surgical methods.
Basic objectives2 Others
Basic objectives -Others In previous studies, patients developed the small white lump on the skin of the treated breast after MRgFUS treatment. This change may be contribute to determine accurate surgical margin of DCIS and avoid a positive margin. This can be associated with a significant decrease in IBTR.
Cancer cell necrosis and death has been evaluated using pathological methods. Plasma genotyping in cell free DNA (cfDNA) analysis is a noninvasive and rapid alternative method of detecting and monitoring the course of disease. If the amount of cfDNA in plasma changes before and after MRgFUS treatment, cfDNA can be used for another methods to assess cancer cell death.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Completely coagulation necrosis of tumor using histopathological methods.
Key secondary outcomes 1 adverse events
2 cosmetically assessment
3 the amount of cfDNA in plasma before and after treatment
4 non palpable lesion become palpable post treatment
5 negative margin of surgical specimen
6 no residual cancer cell in biopsy specimen before treatment

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
Device,equipment
Interventions/Control_1 MRI guided focused ultrasound treatment
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1 Women 18 years and older with DCIS less than 2 cm in diameter
2 Patients signed an informed consent form before participating in this study.
3 Patient who can get an MRI
Key exclusion criteria 1 Metallic implants or other incompatibility with MRI
2 Pregnant or lactating patients
3 Patients not to endure this treatment
4 Patients who are'nt eligible for this study by other reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Nakamura
Organization Showa university
Division name Breast surgery
Zip code
Address 1-5-8 hatanodai shinagawaku tokyo Japan
TEL 03-3784-8000
Email seigonak@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Matsutani
Organization Showa university
Division name Breast surgery
Zip code
Address 1-5-8 hatanodai shinagawaku tokyo Japan
TEL 03-3784-8000
Homepage URL
Email am24791319@gmail.com

Sponsor
Institute Showa university
Institute
Department

Funding Source
Organization Japan Society of Clinical Oncology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 昭和大学病院(東京都)、新都心むさしのクリニック(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 11 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
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 11 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 04 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034490

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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