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
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
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
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
