UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022780
Receipt number R000026255
Scientific Title Assessment of the convection of lymphatic vessel in extremities by indocyanine green (ICG) lypmphography
Date of disclosure of the study information 2016/06/20
Last modified on 2017/06/18 10:44:14

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Basic information

Public title

Assessment of the convection of lymphatic vessel in extremities by indocyanine green (ICG) lypmphography

Acronym

Assessment of the convection of lymphatic vessel in extremities by indocyanine green (ICG) lypmphography

Scientific Title

Assessment of the convection of lymphatic vessel in extremities by indocyanine green (ICG) lypmphography

Scientific Title:Acronym

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 Obstetrics 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

1st name
Middle name
Last name Naoki Unno

Organization

Hamamatsu University School of Medicine

Division name

secondary department of surgery

Zip code


Address

1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka

TEL

053-435-2279

Email

unno@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takaaki Saito

Organization

Hamamatsu University School of Medicine

Division name

secondary department of surgery

Zip code


Address

1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka

TEL

053-435-2279

Homepage URL


Email

unno@hama-med.ac.jp


Sponsor or person

Institute

Secondary department of surgery, HamamatsuUniversity School of Medicine

Institute

Department

Personal name



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)



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

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


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

Enrolling by invitation

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name