UMIN-CTR Clinical Trial

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
Email	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
Email	esan369@yahoo.co.jp

Sponsor
Institute	Dokkyo Medical University Koshigaya Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030766