UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022757 |
|---|---|
| Receipt number | R000026216 |
| Scientific Title | Radiologic-pathologic correlation of the breast using dual energy computed tomography |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2024/06/24 17:47:46 |
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Basic information
Public title
Radiologic-pathologic correlation of the breast using dual energy computed tomography
Acronym
Radiologic-pathologic correlation of the breast using dual energy computed tomography
Scientific Title
Radiologic-pathologic correlation of the breast using dual energy computed tomography
Scientific Title:Acronym
Radiologic-pathologic correlation of the breast using dual energy computed tomography
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine radiologic-pathologic correlation of the breast cancer using dual energy CT and magnetic resonance imaging (MRI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiologic characteristics of breast cancer obtained by dual energy CT
Key secondary outcomes
Correlation between dual energy CT findings and MRI results 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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Dual energy CT and MRI including MR spectroscopy, IDEAL-IQ, T2*map, and intravoxel incoherent motion.
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
Male and Female
Key inclusion criteria
Patients with breast cancer before treatment
Key exclusion criteria
Not applicable
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Yoshizawa |
Organization
Hamamatsu University Hospital
Division name
Department of Radiology
Zip code
431-3192
Address
1-20-1 Handayama, Chuoku, Hamamatsu, Shizuoka
TEL
+81-053-435-2242
nonchan@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Yoshizawa |
Organization
Hamamatsu University Hospital
Division name
Department of Radiology
Zip code
431-3192
Address
1-20-1 Handayama, Chuoku, 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
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuoku, Hamamatsu, Shizuoka
Tel
0534352680
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
| 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 05 | 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
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026216
