The main goal of this STW research program is to develop a reliable non-invasive procedure for in-vivo analysis of the sentinel node to support the treatment of breast cancer. The procedure is based on magnetic particles that are already approved as contrast materials for magnetic resonance imaging (MRI) and will be developed and tested in the operating theatre. The incidence of breast cancer among woman is increasing worldwide. A correct mapping of the lymphatic system is important for the treatment of the patient. The currently used sentinel node approach has disadvantages such as the use of radioactivity and logistical problems. The use of magnetism has several advantages and it can be applied by injecting a magnetic nanoparticle based contrast material, which can be measured with a (handheld) magnetometer on the outside of the body.
An important part of the program is a prospective clinical study on a patient group (n=100) of a commercial magnetometer system (Sentimag) that is developed to localize the sentinel lymph node in vivo in the operating theatre. To get a better insight in the way magnetic particles can be used to detect the sentinel nodes in the lymphatic system, examination of the breast including axillary lymph nodes will be performed in vivo and ex vivo on resected breast tissue in a clinical MRI system with moderate field strength (1.0/1.5T). This is combined with ex vivo high-resolution MRI on resected lymph nodes in a 14T system, accurate magnetometry with a laboratory based instrument (VSM) and classical pathology on the selected lymph nodes.
By combining of state-of-the-art clinical practice and novel experimental techniques in the clinic and the university NIM and ECTM laboratories we aim to obtain the following results:
- An accurate validation for the clinical performance of a novel handheld magnetometer system in a prospective study on the case of breast cancer.
- A technology analysis of existing and novel procedures to localize the sentinel lymph node in this case, including a specification for the required magnetic detection system, the usability in the operating room and the required particle size distribution.
- A design for a novel non-invasive magnetic method to accurately localize and diagnose the status of a lymph node that can be applied in the operating room.
This new knowledge will enable the development of a much broader range of new magnetic instruments for clinical use.
A user committee is formed of industrial and medical partners interested to explore the appealing perspectives of utilizing magnetic nanoparticles for the diagnosis and treatment procedure of patients in a clinical environment. It should be noted that utilization of the results in this program is foreseen in a much larger range of applications than the breast cancer case considered in this program. Lymph node studies are relevant to search and characterise metastasis in almost all variants of this dramatic disease. The present status of magnetic nanoparticle research and applications suggests that the application range of iron-oxide based nanoparticles and magnetic detection has a very large growth potential.
The users committee consists of industrial partners from different disciplines that are interested in this technology and have agreed to contribution substantially to the project:
- Surgery Dept., Medisch Spectrum Twente (www.mst.nl/mammacare).
- Endomagnetics (http://endomagnetics.com)
- Philips Medical Systems (www.healthcare.philips.com)
- Demcon Advanced Mechatronics (www.demcon.nl)
- TMS international (http://www.tmsi.com)