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

NCT02550951 | Unknown DMC

• 1 other identifier: D-1408-124-607
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (5)

• pattern of lymph drainage (Scale of 0 to 5)

  0(abnormal)-10(normal)

  After magnetic resonance lymphangiography scans in up to 2years

• delay of lymph drainage (Scale of 0 to 10)

  0(delay)-10(normal)

  After magnetic resonance lymphangiography scans in up to 2years

• depiction of lymph vessels (Scale of 0 to 10)

  0(Not clarity)-10(Clarity)

  After magnetic resonance lymphangiography scans in up to 2years

• enhancement of inguinal lymph nodes (Scale of 0 to 10)

  0(Not clarity)-10(Clarity)

  After magnetic resonance lymphangiography scans in up to 2years

• Visibility of Lymphatic Duct (Scale of 0 to 10)

  0(Invisible)-10(Clearly visible)

  After magnetic resonance lymphangiography scans in up to 2years

Study Arms (2)

pre-operation Lymphedema

EXPERIMENTAL

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

Procedure: lymphangiography

post-operation Lymphedema

EXPERIMENTAL

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

Procedure: lymphangiography

Interventions

lymphangiography PROCEDURE

post-operation Lymphedema; pre-operation Lymphedema

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 20 years of age
• Patients underwent preoperative and receive magnetic resonance lymphangiography and Lymphoscintigraphy At the postoperative 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• SeungHong Choi, MD,PhD

  Seoul National University Hospital(Radiology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SeoulNUH

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 16, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

KR (1)