MRL in the Upper Extremity

Maastricht University Medical Center20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Lymphedema of Upper Limb

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 0.5 hours per participant

Secondary Outcomes

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.