臨床研究等提出・公開システム

Scientific Title	Surgical margin setting for soft tissue tumors using 2D sheets processed from preoperative imaging data
Public Title	Surgical margin setting for soft tissue tumors using 2D sheets

Contact for Scientific Queries	Name	Ikuta Kunihiro
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai, Showa, Nagoya
	Telephone	+81-52-744-1908
	E-mail	ikuta.kunihiro.r0@f.mail.nagoya-u.ac.jp
Contact for Public Queries	Name	Ikuta Kunihiro
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai, Showa, Nagoya
	Telephone	+81-52-744-1908
	E-mail	ikuta.kunihiro.r0@f.mail.nagoya-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 07, 2024
Actual date of first enrollment
Target sample size		12
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	The study will include patients diagnosed with invasive soft tissue tumors who meet the following criteria: 1) Aged 18 years or older at the time of diagnosis. 2) Have a superficial tumor located in the subcutaneous tissue or above the fascia. 3) Undergo surgical treatment at our institution. 4) The extent of tumor invasion is visible on preoperative contrast-enhanced MRI images.
	Exclusion Criteria	Exclusion criteria: 1) The tumor has ulcerated. 2) Amputation is indicated as the treatment.
	Age Minimum	18age 0month old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Invasive soft tissue tumors
Intervention(s)		The two-dimensional data generated from preoperative images will be transferred onto a sheet and matched to the affected area to visualize the extent of tumor invasion.
Health Condition(s) Keyword		Soft Tissue Neoplasms
Intervention(s) Keyword
Health Condition(s) Code		D013962
Intervention(s) Code
Primary Outcome(s)		Histological margin
Secondary Outcome(s)		Postoperative function, Surgical site complications

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	the ethics committee of Nagoya University Graduate School of Medicine
Address	65 Tsurumai, Showa, Nagoya, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none