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Utility of MR Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy

Primary Purpose

Lymphedema

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lymphangiography
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphedema

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

pre-operation Lymphedema

post-operation Lymphedema

Arm Description

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

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

Outcomes

Primary Outcome Measures

pattern of lymph drainage (Scale of 0 to 5)
0(abnormal)-10(normal)
delay of lymph drainage (Scale of 0 to 10)
0(delay)-10(normal)
depiction of lymph vessels (Scale of 0 to 10)
0(Not clarity)-10(Clarity)
enhancement of inguinal lymph nodes (Scale of 0 to 10)
0(Not clarity)-10(Clarity)
Visibility of Lymphatic Duct (Scale of 0 to 10)
0(Invisible)-10(Clearly visible)

Secondary Outcome Measures

Full Information

First Posted
September 3, 2015
Last Updated
September 15, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02550951
Brief Title
Utility of MR Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy
Official Title
Utility of Magnetic Resonance Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Its usefulness in implementing magnetic resonance angiography for postoperative follow-up of lymph lymphedema should try to evaluate and compare lymphoscintigraphy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre-operation Lymphedema
Arm Type
Experimental
Arm Description
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
Arm Title
post-operation Lymphedema
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
lymphangiography
Primary Outcome Measure Information:
Title
pattern of lymph drainage (Scale of 0 to 5)
Description
0(abnormal)-10(normal)
Time Frame
After magnetic resonance lymphangiography scans in up to 2years
Title
delay of lymph drainage (Scale of 0 to 10)
Description
0(delay)-10(normal)
Time Frame
After magnetic resonance lymphangiography scans in up to 2years
Title
depiction of lymph vessels (Scale of 0 to 10)
Description
0(Not clarity)-10(Clarity)
Time Frame
After magnetic resonance lymphangiography scans in up to 2years
Title
enhancement of inguinal lymph nodes (Scale of 0 to 10)
Description
0(Not clarity)-10(Clarity)
Time Frame
After magnetic resonance lymphangiography scans in up to 2years
Title
Visibility of Lymphatic Duct (Scale of 0 to 10)
Description
0(Invisible)-10(Clearly visible)
Time Frame
After magnetic resonance lymphangiography scans in up to 2years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungHong Choi, MD,PhD
Organizational Affiliation
Seoul National University Hospital(Radiology)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Utility of MR Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy

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