Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-09-10
2023-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Lymphedema patients
MRL examination in lymphedema patients
Magnetic Resonance Lymphography
Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
Healthy volunteers
MRL examination in healthy volunteers
Magnetic Resonance Lymphography
Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
Interventions
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Magnetic Resonance Lymphography
Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
Eligibility Criteria
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Inclusion Criteria
* informed consent
* BMI \< 30 kg/m2
Group A:
\- Secondary lymphedema in the upper extremity
Group B:
\- Healthy volunteers
Exclusion Criteria
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Scannexus
Maastricht, , Netherlands
Countries
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Other Identifiers
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NL72424.068.19
Identifier Type: -
Identifier Source: org_study_id
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