UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038953
Receipt number R000044420
Scientific Title Examination on characteristics and usefulness of DWIBS.
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/22 19:26:18

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Basic information

Public title

Examination on characteristics and usefulness of DWIBS.

Acronym

Examination on characteristics and usefulness of DWIBS.

Scientific Title

Examination on characteristics and usefulness of DWIBS.

Scientific Title:Acronym

Examination on characteristics and usefulness of DWIBS.

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Examine the depiction output of metastatic lesions of breast cancer of DWIBS compared with contrast-enhanced CT.

Basic objectives2

Others

Basic objectives -Others

Compare the ability of DWIBS to evaluate the therapeutic effect on metastatic breast cancer lesions with contrast-enhanced CT.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The ability of DWIBS to depict metastatic lesions of breast cancer compared with contrast-enhanced CT examination.

Key secondary outcomes

Ability to evaluate the therapeutic effect of DWIBS on metastatic lesions of breast cancer.


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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Add DWIBS to contrast CT for breast cancer metastasis search.
Add DWIBS to contrast-enhanced CT to evaluate the therapeutic effect on metastatic lesions of breast cancer.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases diagnosed as breast cancer, for which both contrast-enhanced CT and DWIBS can be performed as a metastasis search.

Key exclusion criteria

Cases where both enhanced CT and DWIBS cannot be performed.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shinsaku
Middle name
Last name KANAZAWA

Organization

SUNKOKAI KOGA Hospital

Division name

Breast Surgery

Zip code

425-0088

Address

2-30-1, Daikakuji, Yaizu-shi, Shizuoka

TEL

0546285500

Email

shikanazawa-gi@umin.net


Public contact

Name of contact person

1st name Shinsaku
Middle name
Last name KANAZAWA

Organization

SUNKOKAI KOGA Hospital

Division name

Breast Surgery

Zip code

425-0088

Address

2-30-1, Daikakuji, Yaizu-shi, Shizuoka

TEL

0546285500

Homepage URL


Email

shikanazawa-gi@umin.net


Sponsor or person

Institute

SUNKOKAI KOGA Hospital

Institute

Department

Personal name



Funding Source

Organization

SUNKOKAI KOGA Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

SUNKOKAI KOGA Hospital

Address

2-30-1, Daikakuji, Yaizu-shi, Shizuoka

Tel

0546285500

Email

shikanazawa-gi@umin.net


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

2020 Year 01 Month 01 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

Open public recruiting

Date of protocol fixation

2019 Year 12 Month 08 Day

Date of IRB

2019 Year 12 Month 20 Day

Anticipated trial start date

2019 Year 12 Month 08 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

2019 Year 12 Month 22 Day

Last modified on

2019 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044420


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name