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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004023
Receipt No. R000002457
Scientific Title Diagnostic perfromance of high-resolution and high-sensitive PET scanner for breast cancer
Date of disclosure of the study information 2010/08/10
Last modified on 2015/02/15

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Basic information
Public title Diagnostic perfromance of high-resolution and high-sensitive PET scanner for breast cancer
Acronym PET mammography for breast cancer
Scientific Title Diagnostic perfromance of high-resolution and high-sensitive PET scanner for breast cancer
Scientific Title:Acronym PET mammography for breast cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the diagnostic performance of the newly-developed dedicated PET scanner for breast imaging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic performance
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Dedicated PET scanner for breast imaging
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 Male and Female
Key inclusion criteria Patients who meet all of the following conditions.
1. Breast cancer is suspected clinically.
2. A PET/CT scan was ordered for staging.
3. Written informed consent was obtained.
Key exclusion criteria Patients who meet at least one of the following conditions.
1. Communication difficulty.
2. General conditions are extremely poor.
3. Informed consent not given.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Nakamoto
Organization Kyoto University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3762
Email ynakamo1@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Nakamoto
Organization Kyoto University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3762
Homepage URL
Email ynakamo1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization None
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 京都大学病院(京都府)
Kyoto University Hospital, Kyoto, Japan

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 09 Day
Last modified on
2015 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002457

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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