UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detectability of malignant breast tumor by portable breast tumor detector
Title of the study (Brief title)	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	Morihito Okada
Organization	Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name	Surgical Oncology
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	Shinsuke Sasada
Organization	Hiroshima University Hospital
Division name	Breast Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.spiedigitallibrary.org/journals/journal-of-medical-imaging/volume-5/issue-02
Results	Detection rate: 100%
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