Low dose SPIO injection for a complete magnetic, radiation-free, procedure for sentinel lymph node detection and metastases evaluation.

The sentinel lymph nodes (SLN) are the first lymph nodes to drain the tumor
site and therefore the first lymph nodes to bare metastases. Hence the
importance to investigate these lymph nodes to define the best treatment
strategy. Currently, the sentinel lymph node procedure is performed using a
magnetic tracer and detection probe. Histopathological investigation of the
resected sentinel lymph nodes should then confirm the presence or absence of
metastases. However, In 80% of patients, the nodes are healthy. At the
Magnetic Detection & Imaging group of the University of Twente, we investigate
a magnetic, radiation-free, procedure for sentinel lymph node detection and
evaluation.
In this study, the aim is to investigate the feasibility of a low-dose SPIO
injection for both evaluation and detection of the thyroid gland in breast
cancer patients. If we can compare MRI images of the lymph nodes with the
pathology images, we may be able to determine the patient's node status using
MRI in the future. In 80% of patients with clean lymph nodes, an SLNB operation
can then possibly be avoided.

To investigate the possibility of using low dose peri-tumoral Magtrace®
injection for a complete magnetic, radiation free, procedure for sentinel
lymph node (SLN) detection and evaluation.
This objective, can be sub-divided in the following objectives:
1) To test the intraoperative detectability of the SLN using low dose Magtrace®
in combination with the SentiMag® system. (regular care)
2) To ex vivo test the best MR imaging sequence for visualization of the SLN
and the detection of SLN metastases in SPIO (Sienna+®)-containing nodes.
3) To ex vivo evaluate the possibility of SPIO(Sienna+® or Magtrace®)-enhanced
metastases detection.
4) To translate results to an in vivo imaging study and protocol.
5) To relate the (semi-quantitative) amount of iron in the excised lymph nodes
to the intraoperative performance of the first and second generation
magnetometers, specifically for the low-dose peritumoral Sienna+® or Magtrace®
injection.

Experimental, minimally invasive, pilot study in breast cancer patients.

Optional in vivo MRI. and ex vivo MRI of the lymph nodes

This research will not be beneficial to the subject. However, the results of
the study will be used to optimize the detection procedure for the sentinel
lymph node as well as the diagnosis of sentinel lymph node metastases. The
study outcomes are used to progress to a radiation-free and minimally invasive
procedure. The benefits are concerning the future patient group, including not
only breast cancer patients, but also melanoma patients and potentially all
solid cancers eligible for SLNB. The information obtained in this study can
also be used in related procedures in colorectal cancer patients. The study
won*t delay diagnosis and won't significantly delay treatment, it won*t cost
extra time for the patient or surgeon and the patient is not subjected to any
acts. The possible delay of the surgergical date will be in the order of days
and the time between surgery and treatment will always be according to the
national guidelines. The only burden is the optional MRI examination. The
patient will not experience any side effects from the two in-vivo MRI scans in
this study. Prior to MRI, patients follow the standard questionnaire that
applies to all other MRI examinations in the MST. With the questionnaire will
be determined if the patient is suitable for the MRI examinations.
The ex-vivo MRI of the lymph nodes and pathological examination of the lymph
nodes takes place outside the presence of the patient himself. So they do not
experience any burden as a result.