Magnetic Resonance Lymphography in Upper Extremity Lymphedema and Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •informed consent
- •BMI < 30 kg/m2
- •Secondary lymphedema in the upper extremity
- •Healthy volunteers
排除标准
- •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
结局指标
主要结局
feasiblity of Magentic Resonance Lymphography (MRL) of the arm by evaluating the MRL output images
时间窗: 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
次要结局
- lymphedema staging by evaluating the MRL output images(0.5 hours per participant)