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
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
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
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
