臨床研究等提出・公開システム

Scientific Title	Sentinel lymph node biopsy using magnetic method and RI method for oral cancer patients
Public Title	SLNB using magnetic and RI methods for oral cancer

Contact for Scientific Queries	Name	Iwai Toshinori Toshinori
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
	Telephone	+81-45-787-2800
	E-mail	iwai104@yokohama-cu.ac.jp
Contact for Public Queries	Name	Iwai Toshinori
	Affiliation	Yokohama City University Hospital
	Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
	Telephone	+81-45-787-2800
	E-mail	iwai104@yokohama-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 25, 2022
Actual date of first enrollment		Jan. 24, 2023
Target sample size		27
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	Early stage oral cancer patients without cervical lymph node metastasis (T1-2N0). Untreated oral cancer patients. Written informed consent was obtained.
	Exclusion Criteria	Patients with iron allergy or pregnancy.
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Oral cancer
Intervention(s)		Superparamagnetic iron oxide and radioisotope are injected around oral cancer 1 day before surgery, and sentinel lymph node mapping is performed using MR lymphography and SPECT/CT. During surgery, sentinel lymph node biopsy is performed using magnetic and gannma probes.
Health Condition(s) Keyword		oral cancer
Intervention(s) Keyword
Health Condition(s) Code		D009062
Intervention(s) Code
Primary Outcome(s)		Detection rate of sentinel lymph node using magnetic and ganmma probes (Number of patients in whom all sentinel lymph nodes mapped on preoperative images were identified/ all patient number)
Secondary Outcome(s)		Detection rate of sentinel lymph node using magnetic and ganmma probes (Number of identified lymph node/ total number of mapped lymph node)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Yokohama City Cancer Research Promotion
Secondary Sponsor	Not applicable

Name of Certified Review Board	Yokohama City University Certified Institutional Review Board
Address	3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan , Kanagawa
Telephone	+81-45-370-7627
E-Mail	ycu_crb@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	April. 18, 2022

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history