Validation of a Magnetic Resonance Lymphography protocol in upper extremity lymphedema and healthy subjects*

Recruiting

Conditions: edema of the arm
lymphedema
10041641

Registration Number: NL-OMON49628

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

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

Group A:
- Secondary lymphedema in the upper extremity
- conservative treatment with compression stockings and manual lymphatic
drainage

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 & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is to determine the feasiblity and applicability of the MRL<br /><br>protocol by evaluating the images of the upper extremity in patients with<br /><br>secondary lymphedema and healthy subjects. MRL images and 3D MIPs will be<br /><br>evaluated by an experienced radiologist and plastic surgeon and scored on the<br /><br>following points: qualitative and quantitative visibility of veins and lymph<br /><br>vessels, location, depth, (abnormal) pattern, diameter, and overall image<br /><br>quality on a scale of 10.<br /><br>Moreover, differences in the lymphatic system between the lymphedema patients<br /><br>and healthy volunteers will be assessed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The images and 3D MIPs will be compared with clinical staging according to the<br /><br>International Society of Lymphology (ISL) classification and Indocyanine green<br /><br>(ICG) lymphography. Clinical classification and ICG Lymphography is performed<br /><br>as standard care at the outpatient-clinic to evaluate lymphedema and as workup<br /><br>for surgical treatment. The dermal backflow stage, as described by, is used in<br /><br>the staging of lymphedema. </p><br>