Projects

Treatment - PRFA

Concept

With combined knowledge and experience in both medical engineering and clinical practice we have developed an instrument to treat breast cancer in a revolutionary cost-effective way. This patented minimally-invasive technique uses radio waves to locally heat up tumor tissue and denaturize cancer cells. It is designated to treat both benign and malignant tumors in an early stage when they have not evolved beyond walnut size. Furthermore our research has shown that this treatment preferentially targets cancerous cells, resulting in the ability to treat tumor strands as well as to leave healthy fatty tissue unaffected [1]. Our PRFA device has been approved by the Swedish Medical Product Agency.

The instrument incorporates a controlling console and a set of treatment electrodes including a vibration hand piece. The system is optimized to fit the needs of the interventional radiologist that will carry out the treatment. The controlling console is equipped with control and logging functions regarding all parameters relevant to the treatment. The Fourier hand piece ensures a gentle insertion of the tretament electrode.

Past Experience

First in-vitro tests have proven this concept to be simple and reliable [2]. A first clinical study with excellent results was conducted at Capio St. Görans and Danderyds Hospital in Stockholm, where 36 patients were treated with our first prototype before undergoing partial or radical mastectomy [3].

Ongoing R&D

Since May 2010 we are conducting a study evaluating PRFA as a adjuvant treatment. Patients are treated three weeks prior to planned partial or radical mastectomy, resulting in further clinical experience and optimization of the instruments and processes involved (see figure 2 and 3). As of May 2011, 17 patients have been treated.

We are currently conducting a feasibility study evaluating the possibility of offering PRFA treatment as an alternative to surgery in elderly inoperable patients. 2 patients have been treated and results are beeing prepared for publication

A study on the treatment of benign breast disease (fibroadenoma) with PRFA will commence shortly.

Permanently we are improving our technology resulting in new treatment prototypes (see figure 1).


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Figure 1. The new PRFA therapy prototype N-2000.





Figure 2. Shown above is the first outpatient-based PRFA treatment of a breast carcinoma conducted on patient number five of the ongoing study. The first picture shows the injection of local anesthetics whereas the second one is taken during ongoing treatment.


Figure 3. The pictures above show the results of PRFA treatment on the second patient of our ongoing study. These MRI images have been obtained with the aid of 13ml ProHance© contrast medium provided by Bracco Diagnostics Inc. The tumor of 11mm can be clearly seen before treatment, whereas after treatment the contrast medium has disappeared, showing a necrotic area of size 25x35mm.



References

[1] Ekstrand V, Wiksell H, Schultz I, et. al "Influence of electrical and thermal properties on RF ablation of breast cancer: Is the tumour preferentially?" BioMedical Engineering Online 2005, 4:41
(download)

[2] Ekstrand V, "Therapeutic applications of acoustic and electromagnetic energy" Ph.D. Thesis, ISBN 91-7140-126-1]
(download)

[3]Wiksell H, Löfgren L, Schässburger KU, et al. "Feasibility study on the treatment of small breast carcinoma using percutaneous US-guided preferential radiofrequency ablation (PRFA)" The Breast (2010), doi:10.1016/j.breast.2010.01.016
(download)

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