UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the convection of lymphatic vessel in extremities by indocyanine green (ICG) lypmphography
Title of the study (Brief title)	Assessment of the convection of lymphatic vessel in extremities by indocyanine green (ICG) lypmphography
Region	Japan

Condition
Condition	healthy individual, patient with maligant tumor (breast cancer and gynecological cancer), patient with the convection interference of lypmphatic vessel
Classification by specialty	Breast surgery Obsterics and gynecology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The assessment method of the convection of lymphatic vessel was only a lymphatic scintigraphy, but we achieved assessment of the morphology and function of the lympatic convection in extremities by the indocyanine green (ICG) lymphography.In this study we compare the assessment of the morphology and lymphatic presssure, transit time between patients with malignant tumor and the convection interference of lypmphatic vessel and healthy individuals.
Basic objectives2	Others
Basic objectives -Others	The assessment method of the convection of lymphatic vessel was only a lymphatic scintigraphy, but we achieved assessment of the morphology and function of the lympatic convection in extremities by the indocyanine green (ICG) lymphography.In this study we compare the assessment of the morphology and lymphatic presssure, transit time between patients with malignant tumor and the convection interference of lypmphatic vessel and healthy individuals.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	lymphatic pressure
Key secondary outcomes	assessment of the morphology of lympatic vessel, transit time

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Healthy individuals have subcutaneous injection of 0.1ml indocyanine green (0.5%) and take the measurement of lymphatic presssure, 14 days later, have the same injection and take the measurement of transit time.
Interventions/Control_2	Patients with malignant tumor have subcutaneous injection of 0.1ml indocyanine green (0.5%) and take the measurement of lymphatic presssure, 14 days later, have the same injection and take the measurement of transit time.
Interventions/Control_3	Patients with the convection interference of lymphatic vessel have subcutaneous injection of 0.1ml indocyanine green (0.5%) and take the measurement of lymphatic presssure, 14 days later, have the same injection and take the measurement of transit time.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy individual, patient with breast cancer and gynecological cancer, patient with the convection interference of lymphatic vessel
Key exclusion criteria	parturient female, nursing female, person with the iodine allergy
Target sample size	150

Research contact person
Name of lead principal investigator	Naoki Unno
Organization	Hamamatsu University School of Medicine
Division name	secondary department of surgery
Address	1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka
TEL	053-435-2279
Email	unno@hama-med.ac.jp

Public contact
Name of contact person	Takaaki Saito
Organization	Hamamatsu University School of Medicine
Division name	secondary department of surgery
Address	1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka
TEL	053-435-2279
Homepage URL
Email	unno@hama-med.ac.jp

Sponsor
Institute	Secondary department of surgery, HamamatsuUniversity School of Medicine
Institute
Department

Funding Source
Organization	HamamatsuUniversity 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	浜松医科大学（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 17 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	2016 Year 06 Month 17 Day
Last modified on	2017 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026255