Nano-MRI on 7 Tesla: A technical validation study in rectal and breast cancer

Lymph node metastases in cancer are an important factor for determining
prognosis and forming an adequate treatment plan. Determining lymph node
status, however, remains quite a challenge. Ferumoxtran-10, an ultrasmall
superparamagnetic iron oxide (USPIO) particle has proven to be a valuable
contrast agent for detecting lymph node metastases using magnetic resonance
imaging (MRI) in various types of cancer (also called nano-MRI). For small
lymph node metastates (<5mm) the diagnostic accuracy of this technique does,
however, drop substantially. Most of the studies that have been performed with
these particles used a 1.5 Tesla or 3 Tesla MRI scanner. We would like to
increase the resolution of nano-MRI by using a 7 Tesla scanner, such that we
can increase the sensitivity of this technique for small lymph nodes. With this
study we would like to validate the results of this technique with pathology in
rectal and breast cancer. In these cancer types many patient undergo a surgical
lymph node dissection with which we can validate our results. Moreover, the
surgical resection specimen in these cancer types allows accurate matching with
the MRI images. If successful this technique could be an alternative to the
current invasive lymph node staging techniques such as surgery. Additionally,
it would complement image guided focal therapies on lymph node metastases such
as radiotherapy.

To validate nano-MRI on 7 Tesla with pathological findings.

Observational study

In this study an MRI scan is performed with a 7 Tesla MRI scanner and a 3 Tesla
MRI scanner, after administrating subjects with an iron contrast agent
(ferumoxtran-10). When administrating ferumoxtran-10, which occurs one day
before the MRI scan over a period of at least 30 minutes, there is a small
probability of a contrast reaction. The administration of the contrast agent
will happen under constant medical supervision and will be stopped/halted if
any reaction should occur to prevent further reaction and reduce any risk of
this procedure. Also, subjects will be screened for any prior contrast reaction.
One day after ferumoxtran-10 is administered, the subject will undergo an MRI
scan in the Erwin L Hahn institute in Essen with a 7 Tesla MRI scanner and an
MRI scan in the Radboudumc in Nijmegen with a 3 Tesla MRI scanner. These MRI
scans come with the same risk clinical MRI scan. The subjects will be screened
for these risks. The total exam will take about 1 hour, during which the
subjects will be instructed not to move.
Summarizing, the study will take place over two days. On day one the contrast
agent is administered in Nijmegen, which will take approximately one hour. On
day two the MRI scan will take place in Essen, which will also take
approximately 1 hour.