UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026800 |
|---|---|
| Receipt number | R000030766 |
| Scientific Title | Clinical study of contrast-enhanced mammography on pre-operative diagnosis of breast cancer |
| Date of disclosure of the study information | 2017/04/06 |
| Last modified on | 2019/07/31 14:36:05 |
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Basic information
Public title
Clinical study of contrast-enhanced mammography on pre-operative diagnosis of breast cancer
Acronym
Clinical study of contrast-enhanced mammography
Scientific Title
Clinical study of contrast-enhanced mammography on pre-operative diagnosis of breast cancer
Scientific Title:Acronym
Clinical study of contrast-enhanced mammography
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare contrast-enhanced mammography and breast enhanced MRI with histopathological results.
To survey patient's satisfaction using questionnaire.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare contrast-enhanced mammography and breast enhanced MRI in the size estimation of preoperative breast cancers using postoperative histology.
Key secondary outcomes
Relationship between detectability and background density of the breast.
Relationship between detectability and the experimental level of radiologist.
Sore of questionnaire on patient's satisfaction.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1.The patients who have histologically proven breast cancer and a plan for operation of the breast cancer in our hospital.
2.The patients who had been taken breast enhanced MRI in our hospital.
3.The patients who can make a position on examination of mammography.
4.The patients who consent in participation in this study with the written consent form.
Key exclusion criteria
1.The patient who has the surgical history on examination area of the chest-wall.
2.The patients who can not take MRI with some medical reasons.
3.The patients who had taken neo-adjuvant chemotherapy.
4.The patients during pregnancy or with possibility.
5.The patients with the medical reasons of contraindication or notice for using iodine contrast agent.
6.The patients with positive inked margin breast cancer in postoperative histology.
7.The patients who are not suitable for participation in this study according to doctor's opinion.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miwako Nozaki |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Radiology
Zip code
Address
2-1-50 Minamikoshigaya Koshigaya,Saitama
TEL
048-965-1111
miwako@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emi Sanjo |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Radiology
Zip code
Address
2-1-50 Minamikoshigaya Koshigaya,Saitama
TEL
048-965-1111
Homepage URL
esan369@yahoo.co.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 04 | Month | 06 | 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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030766
