- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02550951
Utility of MR Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy
Utility of Magnetic Resonance Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy
Study Overview
Detailed Description
Surgical methods include " surgical procedure to make a good lymphatic drain 'and' surgical resection with lymph tissue swelling , significant that two of lymphedema .In recent years, began receiving the spotlight this former method using micro-surgery , inde essential that in order to increase the success rate of these micro-surgery accurately assess the structural abnormalities of preoperative lymphatic and establishing the surgical plan , the primary diagnostic imaging examination of existing lymphedema Since the nuclear medicine examination as to obtain an accurate anatomical information it is also ideal for imaging in the preoperative assessment of lymphedema is precisely that you can not .
In contrast magnetic resonance lymphangiography recently developed a new magnetic resonance imaging techniques that many advantages in precision assessment of lymphedema patients.
First, there are high spatial resolution magnetic resonance lymphangiography through the lymphatic vessels to obtain the correct anatomical information .
Second, magnetic resonance lymphangiography is provide not only information about the functional status of the lymphatic anatomical information .
Third, the magnetic resonance lymphangiography minimally invasive techniques , without exposure to radiation , is relatively easy and safe , that there is a great advantage of being able to diagnose the structural and functional at the same time or later in lymphatic vessels.
The magnetic resonance lymphangiography via the lymphatic advantage given also helps to establish a specific treatment plan , as well as accurate preoperative diagnosis of lymphedema that may contribute to enhance the success of micro-surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 20 years of age
- Patients underwent preoperative and receive magnetic resonance lymphangiography and Lymphoscintigraphy At the postoperative 3 months
Exclusion Criteria:
- Patients with a history of adverse effects on magnetic resonance contrast agents
- Patients with a Decreased renal function(Glomerular filtration rate <30 mL / min)
- Other, maternity, patients with a pacemaker or a cochlear
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pre-operation Lymphedema
before magnetic resonance imaging(MRI), GADOVIST PFS [Bayer Korea] 7.5mL and local anesthetics 0.5m L mixed.
and then 24 gauge needle using about 1 mL by the first , and second , the third the space between the toes intradermal injection , and then about 1-2 minutes , and massage the injection site, and Acquiring an image(coronal T1-weighted three-dimensional gradient-echo sequence) of the foot from a range including up to the pelvis from the comparison with lymphoscintigraphy
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|
|
Experimental: post-operation Lymphedema
before magnetic resonance imaging(MRI), GADOVIST PFS [Bayer Korea] 7.5mL and local anesthetics 0.5m L mixed.
and then 24 gauge needle using about 1 mL by the first , and second , the third the space between the toes intradermal injection , and then about 1-2 minutes , and massage the injection site, and Acquiring an image(coronal T1-weighted three-dimensional gradient-echo sequence) of the foot from a range including up to the pelvis from the comparison with lymphoscintigraphy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pattern of lymph drainage (Scale of 0 to 5)
Time Frame: After magnetic resonance lymphangiography scans in up to 2years
|
0(abnormal)-10(normal)
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After magnetic resonance lymphangiography scans in up to 2years
|
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delay of lymph drainage (Scale of 0 to 10)
Time Frame: After magnetic resonance lymphangiography scans in up to 2years
|
0(delay)-10(normal)
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After magnetic resonance lymphangiography scans in up to 2years
|
|
depiction of lymph vessels (Scale of 0 to 10)
Time Frame: After magnetic resonance lymphangiography scans in up to 2years
|
0(Not clarity)-10(Clarity)
|
After magnetic resonance lymphangiography scans in up to 2years
|
|
enhancement of inguinal lymph nodes (Scale of 0 to 10)
Time Frame: After magnetic resonance lymphangiography scans in up to 2years
|
0(Not clarity)-10(Clarity)
|
After magnetic resonance lymphangiography scans in up to 2years
|
|
Visibility of Lymphatic Duct (Scale of 0 to 10)
Time Frame: After magnetic resonance lymphangiography scans in up to 2years
|
0(Invisible)-10(Clearly visible)
|
After magnetic resonance lymphangiography scans in up to 2years
|
Collaborators and Investigators
Investigators
- Principal Investigator: SeungHong Choi, MD,PhD, Seoul National University Hospital(Radiology)
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-1408-124-607
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