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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027829
Receipt No. R000031885
Scientific Title Study of avoiding axillary surgery in patients with breast cancer by accurate diagnosis of sentinel node metastases using CT and MRI
Date of disclosure of the study information 2017/06/20
Last modified on 2017/06/20

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Basic information
Public title Study of avoiding axillary surgery in patients with breast cancer by accurate diagnosis of sentinel node metastases using CT and MRI
Acronym Study of avoiding axillary surgery in patients with breast cancer by accurate diagnosis of sentinel node metastases using CT and MRI
Scientific Title Study of avoiding axillary surgery in patients with breast cancer by accurate diagnosis of sentinel node metastases using CT and MRI
Scientific Title:Acronym Study of avoiding axillary surgery in patients with breast cancer by accurate diagnosis of sentinel node metastases using CT and MRI
Region
Japan

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

Objectives
Narrative objectives1 To verify whether sentinel node biopsy can be safely spared for patients with breast cancer whose sentinel nodes were diagnosed as metastases-negative by using CT and MRI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes axillary recurrence rate
Key secondary outcomes disease-free survival rate
overall survival rate

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
Other
Interventions/Control_1 Identify the sentinel node by contrast-enhanced CT
Diagnose sentinel node metastases by contrast-enhanced MRI
Avoid sentinel Node biopsy for node-negative patients
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Patients with primary breast cancer who undergo surgery
2) Clinically axillary lymph-nodes negative patients
3) Patients given written informed consent
Key exclusion criteria 1) Patients with contraindication to Iopamidol
2) Patients with contraindication to Ferucarbotran
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Motomura
Organization Osaka General Medical Center
Division name Department of Breast Surgery
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Email motomurak@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Motomura
Organization Osaka General Medical Center
Division name Department of Breast Surgery
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Homepage URL
Email motomurak@hotmail.com

Sponsor
Institute Osaka General Medical Center
Institute
Department

Funding Source
Organization None
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 大阪急性期・総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 20 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2023 Year 12 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
2017 Year 06 Month 20 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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