Proof-of-concept Study of LymphMonitor 1.0 to Assess the Lymphatic Vessel Function
- Conditions
- LymphedemaSecondary Lymphedema
- Interventions
- Combination Product: Lymphatic clearance measurement
- Registration Number
- NCT04393168
- Lead Sponsor
- Nicole Lindenblatt
- Brief Summary
Lymphedema is the consequence of injured lymphatic system and is characterized by chronic, often disabling swelling of am affected body part, often arm or leg. In the western world secondary lymphedema arises most commonly after removal lymph nodes in an operation as a part of cancer treatment (for example from the armpits or the groin region), however it may also develop as a result of radiation, any other operation, infection or injury that destroys a part of lymphatic system. The disease often develops even years after the event. While there is no cure for lymphedema at present, early detection would ensure timely physiotherapy and application of compression garments that significantly slow down or stop the progression of the disease. However, presently used methods of that are used for diagnosis and evaluating the stage of the disease, are either invasive and expensive or inaccurate and can only be performed at specialized medical centres.
Therefore, we developed a simple, affordable and accurate technology, LymphMonitor 1.0 that can allow for testing how efficiently the lymphatic system is functioning. The test can be performed at the local medical centre or potentially even at home.
In this study, we investigate whether LymphMonitor 1.0 technology can distinguish between a healthy and a diseased lymphatic system (in lymphedema). This method may allow early diagnosis of lymphedema so that the development of the disease can be detected and prevented early enough. By participating in the study the lymphedema patients are making an important contribution to increasing the quality of life of lymphedema patients. In LymphMonitor 1.0 method method, a solution of a safe fluorescent dye, indocyanine green, is injected painlessly using tiny microneedles, MicronJet600TM, directly into the skin of the arm or leg. After injection, this dye is removed from the skin only through the lymphatic vessels. The intensity of the fluorescence signal corresponds to the amount of dye left in the skin. The decrease in the fluorescence signal after the injection is measured on the surface on the skin using a new device, LymphMeter 1.0. The faster the dye (and that fluorescence signal) disappears from the surface of the skin, the better the lymphatic system works. Therefore in the arm or leg affected by lymphedema the fluorescence signal will decrease much slower compared to the healthy one.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with unilateral arm or leg lymphedema Lymphatic clearance measurement -
- Primary Outcome Measures
Name Time Method Areas under the normalized clearance curves (AUCs) Fluorescence values measured immediately after injection and 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours after injection. Areas under the normalized clearance curves (AUCs) in healthy and lymphedema limbs measured over 3 hours after injection. To obtain the clearance curve, the fluorescence intensity values at the injection sites in healthy and lymphedema extremities at pre-determined timepoints
- Secondary Outcome Measures
Name Time Method other clearance parameters: clearance constant (k) and half-life of clearance (t1/2); (healthy versus diseased). Fluorescence values measured immediately after injection and 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours after injection. dimensions of the injected dye depot measured by FluoBeam Dimensions will be measured immediately after injection and 1.5 hours and 3 hours after injection. Images of the injection site over time will be recorded using Fluobeam at different and analysed.
Correlation/no correlation of clearance parameters with the extent of the swelling (limb volume) in lymphedema patients. 3 hours
Trial Locations
- Locations (1)
University Hostpial Zurich
🇨🇭Zurich, Switzerland