UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of reflectance diffuse optical tomography system for breast cancer
Acronym	Clinical evaluation of reflectance diffuse optical tomography system for breast cancer
Scientific Title	Clinical evaluation of reflectance diffuse optical tomography system for breast cancer
Scientific Title:Acronym	Clinical evaluation of reflectance diffuse optical tomography system for breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the clinical efficacy of the reflectance diffuse optical tomography system developed by Hamamatsu Photonics K.K. as a diagnostic tool for breast cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of reflectance diffuse optical tomography for breast cancer
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	Reflectance diffuse optical tomography
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 have benign or malignant breast tumors
Key exclusion criteria	Not applicable
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Harumi Sakahara
Organization	Hamamatsu University School of Medicine
Division name	Department of Diagnostic Radiology & Nuclear Medicine
Zip code
Address	1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka
TEL	+81-053-435-2240
Email	sakahara@hama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Nobuko Yoshizawa
Organization	Hamamatsu University Hospital
Division name	Department of Diagnostic Radiology
Zip code
Address	1-20-1 Handayama, Higashiku, Hamamatsu, Shizuoka
TEL	+81-053-435-2242
Homepage URL
Email	nonchan@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu Photonics K.K.
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	2016 Year 06 Month 16 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	Completed
Date of protocol fixation	2015 Year 03 Month 06 Day
Date of IRB	2015 Year 03 Month 03 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 15 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026215