UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)
Title of the study (Brief title)	Subtotal integumentectomy for treatment of malignant melanoma
Region	Japan

Condition
Condition	malignant melanoma
Classification by specialty	Dermatology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In malignant melanoma, in-transit metastasis occur at a frequency of 5 to 10% after the excision of the primary tumor and the regional lymph node dissection. In-transit metastasis is thought to be the cause of proliferation of tumor cells remaining in lymphatic vessels between the primary tumor and the regional lymph nodes. Previously, to prevent in-transit metastasis, subtotal integumentectomy has been performed. Conventionally, it was difficult to noninvasively identify lymphatic vessels, but indocyanine green (ICG) lymphangiography, which was recently developed, visualizes the lymphatic vessels in real time. The purpose of this study is to indicate the effectiveness and safety of subtotal integumentectomy with indocyanine green (ICG) lymphangiography for the treatment of malignant melanoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Relapse-free survival
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We will perform surgery under general anesthesia. We inject Indocyanine Green (ICG) into the primary tumor of the limbs. We use lymphography to confirm sentinel lymph nodes and lymph flow. We conduct sentinel lymph node biopsy. When we confirmed sentinel lymph node metastasis by intraoperative rapid pathologic diagnosis, we perform regional lymph node dissection, excision of lymphatic duct, and resection of primary tumor. All wounds should be wrapped as appropriate so as not to be impossible.
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	Male and Female
Key inclusion criteria	The subject has malignant melanoma of the thigh or brachial primary, and has regional lymph node metastasis. The subject must be over 20 years old at the acquisition date. The subject can be determined to participate in the study at their own will.
Key exclusion criteria	Subjects have a history of severe hypersensitivity and side effects in Indocyanine green (ICG). Subjects suffer from malignant tumors within 5 years. Subjects suffer from acute myocardial infarction, unstable angina, myocarditis, cerebral infarction within 3 months. Subjects have remarkably unstable circulation dynamics due to severe heart failure, arrhythmia, etc. Subject has active infection. Subjects may be pregnant or pregnant Subject's serum albumin is less than 2g/dl. We can not identify lymph flow with ICG during surgery. In addition, when the doctor in charge judges the subject as inappropriate.
Target sample size	10

Research contact person
Name of lead principal investigator	Hironobu Ihn
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Dermatology and Plastic Surgery
Address	1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL	0963735233
Email	ihn-der@kumamoto-u.ac.jp

Public contact
Name of contact person	Jun Aoi
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Dermatology and Plastic Surgery
Address	1-1-1 Honjo, Kumamoto 860-8556, Japan
TEL	0963735233
Homepage URL
Email	junjunaoi@gmail.com

Sponsor
Institute	Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto University Hospital
Organization
Division
Category of Funding Organization	Other
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	2019 Year 02 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 02 Month 21 Day
Anticipated trial start date	2019 Year 02 Month 21 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

Management information
Registered date	2019 Year 02 Month 21 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037409