UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005016
Receipt No. R000005966
Scientific Title Study on a fusion imaging system of ultrasound and MRI in diagnosing breast tumors
Date of disclosure of the study information 2011/02/15
Last modified on 2013/02/03

* 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 Study on a fusion imaging system of ultrasound and MRI in diagnosing breast tumors
Acronym Study on a fusion imaging system of ultrasound and MRI
Scientific Title Study on a fusion imaging system of ultrasound and MRI in diagnosing breast tumors
Scientific Title:Acronym Study on a fusion imaging system of ultrasound and MRI
Region
Japan

Condition
Condition breast tumors
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To optimize the condition of conversion of MRI images to fit into ultrasound images in various breast shapes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the images by ultrasound and MRI with breast shapes and structures
Key secondary outcomes Frequency of adverse events of fusion imaging examination

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 fusion imaging examination
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.Patients who have benign or malignant tumors within the breast
2.Patients who will undergo contrast-enhanced MRI
3.Patients whose performance status are 0 or 1
4.Patients who can give consent in writing to participate in this study of their own will
Key exclusion criteria 1.Patients with cardiac pacemakers
2.Patients with metal or unidentifiable foreign bodies
3.Patients who are in poor general status
4.Patients who are pregnant, suspicion of pregnancy, or lactating
5.Patients who are considered inappropriate for this clinical study by the doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Canon Inc.
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
2011 Year 02 Month 15 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
2011 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2011 Year 03 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 02 Month 03 Day
Last modified on
2013 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.