MRL in the Upper Extremity

Study Overview
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Brief Summary
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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.

Official Title
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Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects

Conditions
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Lymphedema of Upper Limb

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Lymphography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |