UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034258 |
|---|---|
| Receipt number | R000039059 |
| Scientific Title | Lymphedema diagnosis by lower limb lymphangiography using MRI and gadolinium contrast medium |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/09/25 16:20:56 |
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Basic information
Public title
Lymphedema diagnosis by lower limb lymphangiography using MRI and gadolinium contrast medium
Acronym
Lymphangiography with gadolinium
Scientific Title
Lymphedema diagnosis by lower limb lymphangiography using MRI and gadolinium contrast medium
Scientific Title:Acronym
Lymphangiography with gadolinium
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Surgery in general | Vascular surgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and effectiveness of lower limb lymphangiography by MRL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regarding the effectiveness, it is judged effective because the lymph duct can be recognized and recognized. Regarding safety, it is judged as safe that an adverse event does not occur at the 4th week after shooting.
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
After administering gadolinium contrast agent to both lower limbs of lower limb lymphoedema patients, shooting at 3.0 T MRI and evaluate lymphatic vessel running. 8 ml of 0.5 mol / L water-soluble gadolinium preparation and 1 ml of 1% xylocaine are mixed and subcutaneously injected 0.7 - 0.8 ml each at the dorsum side of each toe. Then massage the injection site for 30 seconds and rest for 20 minutes. Under the conditions of Heavy T2 weighted image or 3D T1 high-resolution isotropic volume excitation with fat saturation, the lower leg, the knee joint part and the inguinal part were photographed after 20, 40 and 60 minutes, respectively, and coronal disconnection MIP images of lymphatic vessels are classified by constructing MIP images.
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
An adult patient who is suspected of lymphedema and can maintain rest at the time of examination.
Key exclusion criteria
Patients who can not keep stability. Patients with a history of allergic reactions in gadolinium contrast agent, patients with findings of infection or inflammation at the time of examination. Patient with poor glycemic control.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ishibashi |
Organization
Aichi medical univercity
Division name
Vascular surgery
Zip code
Address
Ngakute city Yazakokarimata 1-1 Aichi prefecture Japan
TEL
0561-62-3311
hiroki.m.i@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Mitsuoka |
Organization
Aichi medical univercity
Division name
Vascular surgery
Zip code
Address
Ngakute city Yazakokarimata 1-1 Aichi prefecture Japan
TEL
0561-62-3311
Homepage URL
hiroki.m.i@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical univercity
Institute
Department
Personal name
Funding Source
Organization
Aichi medical univercity
Organization
Division
Category of Funding Organization
Other
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
YES
Study ID_1
2017-H344
Org. issuing International ID_1
Aichi medical university hospital
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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 25 | 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
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2018 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039059
