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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02550951
• Other study ID #: D-1408-124-607
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 15, 2015
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphedema

Intervention

Procedure:
• lymphangiography

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pattern of lymph drainage (Scale of 0 to 5)	0(abnormal)-10(normal)	After magnetic resonance lymphangiography scans in up to 2years	Yes
Primary	delay of lymph drainage (Scale of 0 to 10)	0(delay)-10(normal)	After magnetic resonance lymphangiography scans in up to 2years	Yes
Primary	depiction of lymph vessels (Scale of 0 to 10)	0(Not clarity)-10(Clarity)	After magnetic resonance lymphangiography scans in up to 2years	Yes
Primary	enhancement of inguinal lymph nodes (Scale of 0 to 10)	0(Not clarity)-10(Clarity)	After magnetic resonance lymphangiography scans in up to 2years	Yes
Primary	Visibility of Lymphatic Duct (Scale of 0 to 10)	0(Invisible)-10(Clearly visible)	After magnetic resonance lymphangiography scans in up to 2years	Yes