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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027227
Receipt No. R000031195
Scientific Title Diagnostic performance of dedicated breast PET scanner with whole-body PET/MR
Date of disclosure of the study information 2017/05/02
Last modified on 2017/11/01

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Basic information
Public title Diagnostic performance of dedicated breast PET scanner with whole-body PET/MR
Acronym Diagnostic performance of dedicated breast PET scanner
Scientific Title Diagnostic performance of dedicated breast PET scanner with whole-body PET/MR
Scientific Title:Acronym Diagnostic performance of dedicated breast PET scanner
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the diagnostic performance of dbPET scanners with an O-shaped detector in patients with known breast cancers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will investigate this study To evaluate the diagnostic performance for early breast cancers of dedicated breast PET with
whole-body PET/MR.
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
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria 1.Breast cancer,Stage Tis,1,2,3 with consent
2. Undergoing ultrasound test and
mammogram.
3. Undergoing MRI
Key exclusion criteria 1. Being possible to take MRI
2. Diabetes
3. having other cancers
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name akashi-tanaka asdako
Organization showa university
Division name breast surgical oncology
Zip code
Address Tokyo, shinagawaku hatanodai 1-5-8
TEL 03-3784-8000
Email s.akashi.tanaka@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name hasimoto rikako
Organization showa university
Division name breast surgical oncology
Zip code
Address Tokyo, shinagawaku hatanodai 1-5-8
TEL 090-7444-6228
Homepage URL
Email rikarika10063@gmail.com

Sponsor
Institute Showa university
Institute
Department

Funding Source
Organization Shimadzu, kyoto, japan
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 02 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
2015 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Operative patients in showa university
hospital are taken whole-body PET and dbPET in Midtown clinic Tokyo bey which is a joint research facility.we currently have renewed this study to find out the quick response of neoadjuvant chemotherapy for breast cancer patients.

Management information
Registered date
2017 Year 05 Month 02 Day
Last modified on
2017 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031195

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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