UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036368 |
|---|---|
| Receipt number | R000041373 |
| Scientific Title | Construction of optimal algorithm for image reconstruction from breast measurements with time-resolved spectroscopy system (TRS-21-6W) |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/04/04 17:27:09 |
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Basic information
Public title
Construction of optimal algorithm for image reconstruction from breast measurements with time-resolved spectroscopy system (TRS-21-6W)
Acronym
Construction of optimal algorithm for image reconstruction from breast measurements with time-resolved spectroscopy system (TRS-21-6W)
Scientific Title
Construction of optimal algorithm for image reconstruction from breast measurements with time-resolved spectroscopy system (TRS-21-6W)
Scientific Title:Acronym
Construction of optimal algorithm for image reconstruction from breast measurements with time-resolved spectroscopy system (TRS-21-6W)
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to construct optimal algorithm for image reconstruction and an appropriate method for data collection in breast cancer measurements with time-resolved spectroscopy system (TRS-21-6W).
Basic objectives2
Others
Basic objectives -Others
Construction of optimal algorithm for image reconstruction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will construct optimal algorithm for image reconstruction and an appropriate method for data collection in breast cancer measurements to obtain images of normal and tumor breasts shows values close to expected or known parameter values.
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
The breast measurements will be carried out using TRS-21-6W in normal and tumor breasts in combination with an ultrasonography system.
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
patients with breast cancer
Key exclusion criteria
Patients with difficulty in measurement by TRS-21-6W
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogura |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku Hamamatsu
TEL
053-435-2641
h.ogura@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Yoshizawa |
Organization
Hamamatsu University School of Medicine
Division name
Department of Diagnostic Radiology & Nuclear Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku Hamamatsu
TEL
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
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1 Handayama, Higashiku Hamamatsu
Tel
053-435-2680
rinri@hama-med.ac.jp
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
| 2019 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041373
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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