Proof-of-concept Study of LymphMonitor 1.0 to Assess the Lymphatic Vessel Function
Condition: Lymphedema; Secondary Lymphedema
MeSH terms: Lymphedema
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Lymphatic clearance measurement
Intervention type(s): Combination Product
Intervention description(s): The indocyanine green in 5% human albumin solution (tracer) (50 μL) will be injected intradermally in both forearms or both lower legs using MicronJet600 microneedles paying attention to the contralateral symmetry of the injections. The signal at the injection sites will be measured over time using a hand-held portable device LymphMeter 1.0 for the total duration of 3 h. In the first hour, the signal will be measured every 15 minutes followed by measurements every half an hour. Immediately after injection (t=0 h), 1.5 h and 3 h after injection the skin area occupied by the tracer will be measured using a standard near-infrared camera, Fluobeam. The dermal reaction at the injection site will be assessed by observations for presence of redness/erythema and measuring its extent according to the needs. The patient will be constantly observed for the signs of allergic reactions, skin irritations or intolerances.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: lymphedema; secondary lymphedema; fluorescence; indocyanine green