UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003119
Receipt No. R000003764
Scientific Title MR lymphangiography for preoperative assesment of secondary lymhedema
Date of disclosure of the study information 2010/02/01
Last modified on 2010/01/31

* 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 MR lymphangiography for preoperative assesment of secondary lymhedema
Acronym MR lymphangiography for secondary lymhedema
Scientific Title MR lymphangiography for preoperative assesment of secondary lymhedema
Scientific Title:Acronym MR lymphangiography for secondary lymhedema
Region
Japan

Condition
Condition lymphedema
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess efficasy and safety of MR lymphangiography as preoperative examination for secondary lymphedema
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1. To make sure correspondence of the location and direction of lymph vessels detected by MR lymphgraphy with that of lymph vessels detected by intraoperative ICG fluorescence lymphangiography
2.To make sure if lymph vessel detected by MR lymphgraphy is actually found in operation and it have its proper function that makes the operative procedure possible
3.To make sure the extent of pain after subcutaneous injection of contrast medium for MR lymphangiography
Key secondary outcomes

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 Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 MR lymphangiography
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Secondary lymphedema in our hospital
2.Patients whose primary disease is controlled
3.Patients who request the operation
4.Patiens who have no problem about MRI using contrast medium
5.Patients who have informed consent to this trial
Key exclusion criteria 1.Patients who are against the inclusion criteria
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Sawaizumi
Organization Cancer Institute Ariake Hospital
Division name Plastic and reconstructive surgery
Zip code
Address 3-8-31, Ariake, Koutou-ku, Tokyo
TEL 03-3520-0111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Imai
Organization Cancer Institute Ariake Hospital
Division name Plastic and reconstructive surgery
Zip code
Address 3-8-31, Ariake, Koutou-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email kimai@spa.att.ne.jp

Sponsor
Institute Cancer Institute Ariake Hospital
Institute
Department

Funding Source
Organization Cancer Institute Ariake Hospital
Organization
Division
Category of Funding Organization Non profit foundation
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 癌研究会有明病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 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
2009 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 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
2010 Year 01 Month 31 Day
Last modified on
2010 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003764

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.