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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026181
Receipt No. R000029947
Scientific Title Detectability of malignant breast tumor by portable breast tumor detector
Date of disclosure of the study information 2017/02/24
Last modified on 2019/01/23

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Basic information
Public title Detectability of malignant breast tumor by portable breast tumor detector
Acronym PORBRATOR study
Scientific Title Detectability of malignant breast tumor by portable breast tumor detector
Scientific Title:Acronym PORBRATOR study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the ability to detect breast tumors by portable breast tumor detection device in patients with malignant breast tumor with a maximum diameter of 1 cm or more.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Detection rate of malignant breast tumor
Key secondary outcomes Accuracy of breast tumor position
Adverse event

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 Measurement by portable breast tumor detector
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 1. Female older than 20 years old.
2. Patients with histologically confirmed malignant breast tumor.
3. Maximum tumor size is 1 cm or more by two or more arbitrary image examination; mammography, breast ultrasonography, contrast breast MRI and FDG-PET examination.
4. Signed informed consent
Key exclusion criteria 1. History of chemotherapy or radiotherapy.
2. Hypersensitivity to ABS plastic resin.
3. Having a pacemaker.
4. Decision of the physician
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihito Okada
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Surgical Oncology
Zip code
Address 1-2-3 Kasumi, Minami-Ku, Hiroshima City, Hiroshima 734-8551, Japan
TEL 082-257-5869
Email morihito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Sasada
Organization Hiroshima University Hospital
Division name Breast Surgery
Zip code
Address 1-2-3 Kasumi, Minami-Ku, Hiroshima City, Hiroshima 734-8551, Japan
TEL 082-257-5555
Homepage URL
Email shsasada@hiroshima-u.ac.jp

Sponsor
Institute Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.spiedigitallibrary.org/journals/journal-of-medical-imaging/volume-5/issue-02
Number of participants that the trial has enrolled
Results
Detection rate: 100%
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
2016 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 24 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 06 Month 10 Day
Date trial data considered complete
2017 Year 06 Month 20 Day
Date analysis concluded
2017 Year 08 Month 30 Day

Other
Other related information 1. http://www.nature.com/articles/s41598-017-16617-6
2. https://www.spiedigitallibrary.org/journals/Journal-of-Medical-Imaging/volume-5/issue-2/025502/Portable-impulse-radar-detector-for-breast-cancer--a-pilot/10.1117/1.JMI.5.2.025502.short?SSO=1

Management information
Registered date
2017 Year 02 Month 16 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029947

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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