UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023614
Receipt number R000027192
Scientific Title Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer
Date of disclosure of the study information 2016/08/13
Last modified on 2016/08/13 10:34:17

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Basic information

Public title

Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer

Acronym

Detection of micro-metastasis of lymph node in patients with breast cancer

Scientific Title

Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer

Scientific Title:Acronym

Detection of micro-metastasis of lymph node in patients with breast cancer

Region

Japan


Condition

Condition

Patients who will diagnosed with breast cancer, and will be performed radical breast surgery without neoadjuvant chemotherapy.
Patients who will diagnosed with clinically negative lymph node metastasis by using preoperative palpation, CT and MRI.

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether the quantitative measurement of blood vessel density by ultrasound with microbubbles enables the diagnosis of lymph nodes micrometastases in breast cancer patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate whether the quantitative measurement of blood vessel density by contrast-enhanced ultrasound enables the diagnosis of lymph nodes micrometastases in breast cancer patients by setting appropriate threshold.

Key secondary outcomes



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

Patients who will be diagnosed with breast cancer and be performed radical breast surgery.
Patients who will be performed surgery without neoadjuvant chemotherapy.
Patients who will not be diagnosed with lymph node metastasis by palpation, CT and MRI.

Key exclusion criteria

Patients who will have possibility of pregnancy or patients who will be breast-feeding woman.
Patients who will have allergy for contrast agent of ultrasound, egg and egg products.
Patients who will have right-to-left shunt.
Patients who will have severe heart disease or lung disease.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoko Mori

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Diagnostic Radiology

Zip code


Address

1-1, Seiryomachi, Aobaku, Sendai, Miyagi

TEL

022-717-7312

Email

naokomori7127@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Naoko Mori

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Diagnostic Radiology

Zip code


Address

1-1, Seiryomachi, Aobaku, Sendai, Miyagi

TEL

022-717-7312

Homepage URL


Email

naokomori7127@gmail.com


Sponsor or person

Institute

Diagnostic Radiology,Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

JSPS(Japan Society for promotion of Science)

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 08 Month 13 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

2013 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 11 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

Contrast-enhanced ultrasound will be performed for patients with clinically negative lymph node metastasis.
After surgery, patients were classified into two groups (positive- and negative lymph node metastasis). We will evaluate whether contrast-enhanced ultrasound will differentiate negative- and positive group by using quantitative analysis.


Management information

Registered date

2016 Year 08 Month 13 Day

Last modified on

2016 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027192


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name