UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022755
Receipt number R000026215
Scientific Title Clinical evaluation of reflectance diffuse optical tomography system for breast cancer
Date of disclosure of the study information 2016/06/16
Last modified on 2019/03/27 14:13:58

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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

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

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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026215


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name