UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative analysis of contrast-enhanced ultrasound using microbubble to detect micro-metastasis of lymph node in patients with breast cancer
Title of the study (Brief title)	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	Naoko Mori
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Diagnostic Radiology
Address	1-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL	022-717-7312
Email	naokomori7127@gmail.com

Public contact
Name of contact person	Naoko Mori
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Diagnostic Radiology
Address	1-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL	022-717-7312
Homepage URL
Email	naokomori7127@gmail.com

Sponsor
Institute	Diagnostic Radiology,Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027192