UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034258
Receipt No. 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

* 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 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
Email 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
Email hiroki.m.i@aichi-med-u.ac.jp

Sponsor
Institute Aichi medical univercity
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039059

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.