UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027829
Receipt number 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 2022/06/23 09:11:21

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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 Kazuyoshi
Middle name
Last name Motomura

Organization

Osaka General Medical Center

Division name

Department of Breast Surgery

Zip code

558-8558

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 Kazuyoshi
Middle name
Last name Motomura

Organization

Osaka General Medical Center

Division name

Department of Breast Surgery

Zip code

558-8558

Address

3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka

TEL

06-6692-1201

Homepage URL


Email

motomurak@hotmail.com


Sponsor or person

Institute

Osaka General Medical Center

Institute

Department

Personal name



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

Osaka General Medical Center

Address

3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka

Tel

06-6692-1201

Email

rinri@gh.opho.jp


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

Completed

Date of protocol fixation

2017 Year 05 Month 25 Day

Date of IRB

2017 Year 06 Month 14 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2027 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

2022 Year 06 Month 23 Day



Link to view the page

Value
https://center6.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