MRL in the Upper Extremity

Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects

Objective: The aim of this study is to examine the feasibility and applicability of the MRL protocol for the upper extremity in Maastricht University Medical Center, and to examine the differences of the lymphatic system between lymphedema patients and healthy volunteers.

Study design: An explorative study of an MRL protocol for the upper extremity in Maastricht University Medical Center+.

Study population: There are two study groups. The first group (n=10) consists of patients with secondary lymphedema in the upper extremity. The second group (n=10) consists of healthy volunteers.

Intervention (if applicable):

All participants will undergo an MRL examination with the same protocol, developed in a previous 'proof of principle' study, in the Maastricht University Medical Center+.

After localizer scans, a T2-weighted sequence is used. Then a T1-weighted sequence will be made before the injection of contrast. After the injection of the contrast agent a T1-weighted sequences of the upper and lower arm are performed alternately.

Main study parameters/endpoints:

The primary outcome is to determine the feasibility and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects.

The secondary outcome is to assess the value of MRL in staging lymphedema.

Study Overview

• Status: Completed
• Conditions: Lymphedema of Upper Limb
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Lymphography

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Scannexus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older
• informed consent
• BMI < 30 kg/m2

Group A:

- Secondary lymphedema in the upper extremity

Group B:

- Healthy volunteers

Exclusion Criteria:

• Active skin infection/erysipelas in the arm.
• Known allergy for a contrast agent
• History of surgical intervention in the arm.
• Contraindications for MRI with contrast; pregnancy, metals, prostheses, renal insufficiency, claustrophobia
• Active cancer
• Distant metastases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lymphedema patients; MRL examination in lymphedema patients	Diagnostic test: Magnetic Resonance Lymphography; Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
Other: Healthy volunteers; MRL examination in healthy volunteers	Diagnostic test: Magnetic Resonance Lymphography; Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images	Describing lymphatic vessel characteristics in terms of size, diameter and course, and lymphedema symptoms such as dermal backflow or obstruction	0.5 hours per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lymphedema staging by evaluating the MRL output images	Describing lymphedema stage, based on lymphatic vessel charasteristics and lymphedema symptoms as found at primary outcome. This is compared with ISL (clinical) lymphedema stage and ICG lymphography stage.	0.5 hours per participant

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: NL72424.068.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No