臨床研究等提出・公開システム

Japanese

Date of registration	June. 04, 2021
Last modified on	July. 25, 2025
Trial ID	jRCTs051210034

Scientific Title	Clinical Trial for the Evaluation of Efficacy and Safety of Contrast Enhanced Ultrasonography-guided Sentinel Lymph Node Biopsy after Introducing Twirl Breast Marker for Axillary Lymph Node-positive Breast Cancer
Public Title	Contrast Enhanced Ultrasonography-guided Sentinel Lymph Node Biopsy after Introducing Twirl Breast Marker for Axillary Lymph Node-positive Breast Cancer

Contact for Scientific Queries	Name	Shimazu Kenzo
	Affiliation	Osaka University Hospital
	Address	2-15 Yamada-oka, Suita city, Osaka, 565-0871, Japan
	Telephone	+81-6-6879-3772
	E-mail	kshimazu@onsurg.med.osaka-u.ac.jp
Contact for Public Queries	Name	Miyake Tomohiro
	Affiliation	Osaka University Hospital
	Address	2-15 Yamada-oka, Suita city, Osaka, 565-0871, Japan
	Telephone	+81-6-6879-3772
	E-mail	t_miyake@onsurg.med.osaka-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 04, 2021
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients with the ability to consent who are 20 years old or older and younger than 90 years old at the time of obtaining informed consent (2) Clinically T1-2N1M0 breast cancer patients with 1 to 2 positive axillary lymph nodes of whicn at least one axillary lymph node has been confirmed to harbor metastasis by fine needle aspiration cytology (3) Patients whose condition are expected to be stable for longer than 6 months at the time of obtaining the informed consent (4) Patients for whom a written consent has been obtained for participation in this study
	Exclusion Criteria	(1) Patients with palpable hard nodes (2) Patients with radiologically proven matted nodes or gross extranodal disease (3) Patients who have been treated with preoperative chemotherapy or hormonal therapy for breast cancer (4) Patients who are during or possibilities of pregnancy (5) Patients who are allergic to metal or egg (6) Patients with coronary artery disease (7) Patients who seem not eligible for the present study
	Age Minimum	20age old over
	Age Maximum	90age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		Breast cancer
Intervention(s)		Hookwire-guided sentinel lymph node biopsy using contrast-enhanced ultrasonography after introducing Twirl breast markers
Health Condition(s) Keyword		Breast cancer
Intervention(s) Keyword		Sentinel lymph node biopsy
Health Condition(s) Code		D001943
Intervention(s) Code		D021701
Primary Outcome(s)		Ratio of patients who have spared axillary lymph node dissection
Secondary Outcome(s)		Proportion of Twirl-LNs to sentinel lymph nodes Tumor burden in Twirl-LN Number of metastatic lymph nodes among non-sentinel lymph nodes Ratio of Twirl-LN which could be sampled by means of intraoperative ultrasonography and conventional sentinel lymph node biopsy method, i.e., dye or radio-isotope method

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Source of Monetary Support	Japan Society for the Promotion of Science
Secondary Sponsor	Not applicable

Name of Certified Review Board	Osaka University Clinical Research Review Committee
Address	2-2 Yamada-oka, Suita city, Osaka
Telephone	+81-6-6210-8296
E-Mail	handai-nintei@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	May. 21, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	July. 25, 2025	(this page)	Changes
4	May. 14, 2024	Detail	Changes
3	July. 28, 2022	Detail	Changes
2	May. 25, 2022	Detail	Changes
1	June. 04, 2021	Detail

List of change history