Lymphedema of Upper Limb
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMagnetic Resonance Lymphography
Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
Sponsors
Maastricht University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images | 0.5 hours per participant | Describing lymphatic vessel characteristics in terms of size, diameter and course, and lymphedema symptoms such as dermal backflow or obstruction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lymphedema staging by evaluating the MRL output images | 0.5 hours per participant | 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. |
Countries
Netherlands
Outcome results
None listed