UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035972
Receipt number R000037409
Scientific Title Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)
Date of disclosure of the study information 2019/02/22
Last modified on 2019/02/21 18:27:51

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Basic information

Public title

Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)

Acronym

Subtotal integumentectomy for treatment of malignant melanoma

Scientific Title

Subtotal integumentectomy for treatment of malignant melanoma with indocyanine green(ICG)

Scientific Title:Acronym

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

1st name
Middle name
Last name Hironobu Ihn

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Dermatology and Plastic Surgery

Zip code


Address

1-1-1 Honjo, Kumamoto 860-8556, Japan

TEL

0963735233

Email

ihn-der@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Aoi

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Dermatology and Plastic Surgery

Zip code


Address

1-1-1 Honjo, Kumamoto 860-8556, Japan

TEL

0963735233

Homepage URL


Email

junjunaoi@gmail.com


Sponsor or person

Institute

Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2019 Year 02 Month 21 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name