UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of local injection of indocyanine green for visualizing lymphatic malformation
Title of the study (Brief title)	Visualization of lymphatic malformation
Region	Japan

Condition
Condition	lymphatic malformation
Classification by specialty	Surgery in general Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Visualization of lymphatic malformation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing the area of lymphatic malformation detected by indocyanine green injection with other image diagnosis
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Local injection of indocyanine green
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	1 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	lymphatic malformation patients
Key exclusion criteria	Having allergy to iodine
Target sample size	25

Research contact person
Name of lead principal investigator	Yujiro Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pediatric Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Email	tanakayujiro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yujiro Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Pediatric Surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Homepage URL
Email	shounigeka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 01 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 25 Day
Anticipated trial start date	2017 Year 03 Month 01 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	2017 Year 01 Month 25 Day
Last modified on	2018 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029720