UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031880 |
|---|---|
| Receipt number | R000035993 |
| Scientific Title | Validation for safety and efficacy of axillary reverse mapping using ICG in terms of prevention for lymphedema of upper limb in breast cancer |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2021/03/31 21:54:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation for safety and efficacy of axillary reverse mapping using ICG in terms of prevention for lymphedema of upper limb in breast cancer
Acronym
Validation for safety and efficacy of axillary reverse mapping using ICG
Scientific Title
Validation for safety and efficacy of axillary reverse mapping using ICG in terms of prevention for lymphedema of upper limb in breast cancer
Scientific Title:Acronym
Validation for safety and efficacy of axillary reverse mapping using ICG
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform a pilot study about the axillary reverse mapping using ICG and PhotoDynamic Eye for prevention of lymph edema in breast cancer patients who are undergone axillary lymph node dissection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
percentage of lymph edema in upper limb
adverse events
Key secondary outcomes
percentage of detection of lymph ducts
detail of lymph ducts
local recurrence rate of axillary lymph nodes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We would detect lymph ducts from upper limb during axillary lymph node dissection and preserve the lymph ducts.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who will be performed axillary lymph node dissection with clinically metastasis-positive status in axillary lymph nodes or metastasis positive status proven by a sentinel lymph node biopsy.
Key exclusion criteria
patients with sensitivity to ICG or other drugs
pregnant patients
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagayasu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgical Oncology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7304
nagayasu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Otsubo |
Organization
Nagasaki University Hospital
Division name
Surgical Oncology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7304
Homepage URL
rotsubo@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
The clinical research review board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki-shi
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
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
| 2018 | Year | 03 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 24 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035993
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
