UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lymphedema diagnosis by lower limb lymphangiography using MRI and gadolinium contrast medium
Title of the study (Brief title)	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	Hiroyuki Ishibashi
Organization	Aichi medical univercity
Division name	Vascular surgery
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	Hiroki Mitsuoka
Organization	Aichi medical univercity
Division name	Vascular surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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