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

September 15, 2015 updated by: Seung Hong Choi, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)
After magnetic resonance lymphangiography scans in up to 2years
delay of lymph drainage (Scale of 0 to 10)
Time Frame: After magnetic resonance lymphangiography scans in up to 2years
0(delay)-10(normal)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SeungHong Choi, MD,PhD, Seoul National University Hospital(Radiology)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-1408-124-607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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