UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038953 |
|---|---|
| Receipt number | R000044420 |
| Scientific Title | Examination on characteristics and usefulness of DWIBS. |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/12/22 19:26:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination on characteristics and usefulness of DWIBS.
Acronym
Examination on characteristics and usefulness of DWIBS.
Scientific Title
Examination on characteristics and usefulness of DWIBS.
Scientific Title:Acronym
Examination on characteristics and usefulness of DWIBS.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine the depiction output of metastatic lesions of breast cancer of DWIBS compared with contrast-enhanced CT.
Basic objectives2
Others
Basic objectives -Others
Compare the ability of DWIBS to evaluate the therapeutic effect on metastatic breast cancer lesions with contrast-enhanced CT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ability of DWIBS to depict metastatic lesions of breast cancer compared with contrast-enhanced CT examination.
Key secondary outcomes
Ability to evaluate the therapeutic effect of DWIBS on metastatic lesions of breast cancer.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Add DWIBS to contrast CT for breast cancer metastasis search.
Add DWIBS to contrast-enhanced CT to evaluate the therapeutic effect on metastatic lesions of breast cancer.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases diagnosed as breast cancer, for which both contrast-enhanced CT and DWIBS can be performed as a metastasis search.
Key exclusion criteria
Cases where both enhanced CT and DWIBS cannot be performed.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinsaku |
| Middle name | |
| Last name | KANAZAWA |
Organization
SUNKOKAI KOGA Hospital
Division name
Breast Surgery
Zip code
425-0088
Address
2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL
0546285500
shikanazawa-gi@umin.net
Public contact
Name of contact person
| 1st name | Shinsaku |
| Middle name | |
| Last name | KANAZAWA |
Organization
SUNKOKAI KOGA Hospital
Division name
Breast Surgery
Zip code
425-0088
Address
2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL
0546285500
Homepage URL
shikanazawa-gi@umin.net
Sponsor or person
Institute
SUNKOKAI KOGA Hospital
Institute
Department
Personal name
Funding Source
Organization
SUNKOKAI KOGA Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SUNKOKAI KOGA Hospital
Address
2-30-1, Daikakuji, Yaizu-shi, Shizuoka
Tel
0546285500
shikanazawa-gi@umin.net
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
| 2020 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044420
