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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphedema patients | Other | MRL examination in lymphedema patients |
|
| Healthy volunteers | Other | MRL examination in healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Lymphography | Diagnostic Test | Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system |
|
| 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 |
| 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 |
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Inclusion Criteria:
Group A:
- Secondary lymphedema in the upper extremity
Group B:
- Healthy volunteers
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scannexus | Maastricht | Netherlands |
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