UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005680 |
|---|---|
| Receipt number | R000006719 |
| Scientific Title | Efficacy of contrast enhanced spectral mammography (CESM) |
| Date of disclosure of the study information | 2011/05/31 |
| Last modified on | 2011/05/31 14:52:09 |
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Basic information
Public title
Efficacy of contrast enhanced spectral mammography (CESM)
Acronym
Efficacy of contrast enhanced spectral mammography (CESM)
Scientific Title
Efficacy of contrast enhanced spectral mammography (CESM)
Scientific Title:Acronym
Efficacy of contrast enhanced spectral mammography (CESM)
Region
| Japan |
Condition
Condition
Category 3 or more in mammography or ultrasound
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of CESM
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
accuracy rate
Key secondary outcomes
true positive rate, false negative rate, true negative rate, false positive rate, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CESM
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
1) Category 3 or more in mammography or ultrasound within one year
2)Female aged over 20
3) Written informed consent
Key exclusion criteria
1) respiratory disorder; asthma, chronic obstractive respiratory disease, lung cancer 2) history of allergic reaction to iodinate contrast medium, drug or food 3) history of thyroid disease 4) diabetes mellitus taking metformin 5) brain disease, heart disease, liver disease or kidney disease 6) acute pancreatitis, microglobulinemia, multiple myeloma, tetany or phenochromocytoma 7) History of breast enlargement injection or surgery 8) pregnancy or during lactation 9) mental disorder 10) participating or have participated within 3 months in other trials 11) other disorders which may prevent accurate evaluation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Nakamura |
Organization
Showa University
Division name
Department of breast surgical oncology
Zip code
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo, 142-8666, Japan
TEL
03-3784-8511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Mori |
Organization
Showa University
Division name
Department of breast surgical oncology
Zip code
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo, 142-8666, Japan
TEL
03-3784-8511
Homepage URL
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Department of breast surgical oncology, Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
昭和大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 31 | 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
| 2011 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 31 | Day |
Last modified on
| 2011 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006719
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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