UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients required vacuum-assisted biopsy
Acronym	To evaluate the effectiveness of dbPET in patients required vacuum-assisted biopsy
Scientific Title	A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients required vacuum-assisted biopsy
Scientific Title:Acronym	To evaluate the effectiveness of dbPET in patients required vacuum-assisted biopsy
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 ability of dedicated breast positron emission tomography (dbPET) can do predict the outcome of pathological results of the patients to require the biopsy for mammography calcifications.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison with the pathological findings
Key secondary outcomes	Comparison with MRI diagnosis

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	To perform dbPET scan for patients with mammography calcifications that require biopsy, and to analyze the correlation between the FDG uptake of the lesions and pathological diagnosis or the MRI diagnosis.
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	Not applicable
Gender	Female
Key inclusion criteria	The patients with mammography calcifications that require biopsy
Key exclusion criteria	1.Pregnant and possibly pregnant women 2.Other patients determined to be inappropriate by physician
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Sadatoshi Middle name Last name Sugae
Organization	Graduate School of Medicine, Yokohama City University
Division name	Department of gastroterological surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL	045-787-2650
Email	sugae@yokohama-cu.ac.jp

Public contact
1st name of contact person	1st name Sadatoshi Middle name Last name Sugae
Organization	Graduate School of Medicine, Yokohama City University
Division name	Department of gastroterological surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL	045-787-2650
Homepage URL
Email	sugae@yokohama-cu.ac.jp

Sponsor
Institute	Department of gastroterological surgery, Graduate School of Medicine, Yokohama City University
Institute
Department

Funding Source
Organization	Department of gastroterological surgery, Graduate School of Medicine, Yokohama City 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	Department of gastroterological surgery, Graduate School of Medicine, Yokohama City University
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
Tel	045-787-2650
Email	sugae@yokohama-cu.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	2013 Year 12 Month 09 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	12
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	2013 Year 07 Month 29 Day
Date of IRB	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 12 Month 09 Day
Last follow-up date	2018 Year 12 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	2013 Year 12 Month 07 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014650