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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031880
Receipt No. 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

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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
Email 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
Email rotsubo@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email 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
URL(English) https://upload.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


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