UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003119 |
|---|---|
| Receipt number | 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 17:16:07 |
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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
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
kimai@spa.att.ne.jp
Sponsor or person
Institute
Cancer Institute Ariake Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003764
