Preoperative detection of lymph node metastases in pancreatic and periampullary carcinoma using ultrasmall super paramagnetic iron oxide nanoparticle ferumoxtran-10.

Pancreatic ductal adenocarcinoma (PDA) is a devastating disease with a dismal
prognosis which has not improved substantially in the past 40 years. A good
preoperative TNM staging is of importance to determine the appropiate therapy
and prognosis. An important negative prognostic factor is the presence of
para-aortic lymph node metastases which are regarded as distant metastases and
therefore precludes a curative resection of the tumor.
In only 33% of cases para-aortic lymph node metastases are detected
preoperatively, due to the low sensitivity of CT and conventional MRI.
Moreover, after a curative resection in 70% of patients liver metastases or a
local recurrence of disease occurs usually in the lymph nodes of the mesenteric
root and in the para-aortic lymph nodes. This suggests that at the time of
surgery micrometastases in the liver and lymph nodes were already present.
Determining lymph node status preoperatively, however, is 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). With this study we would like to validate the results of this
technique with pathology in patients with pancreatic and periampullary cancer.
Ultimately improved preoperative staging of pancreatic and periampullary cancer
leads to an improved treatment stratification plan. Demonstration of
para-aortic lymph nodes could prevent an unnecessay operation with its
associated morbidity and mortality and therefore improve quality of life.
Additionally, if metastatic lymph nodes are present, it could complement image
guided focal therapies on lymph node metastases such as radiotherapy and
electroporesis.

The first objective is to improve preoperative staging with 3T NANO-MRI
regarding the detection of lymph node metastases in patients with a pancreatic
or periampullary carcinoma when compared to a conventional contrast-enhanced CT
or MRI. Other objectives are to improve a) the detection of liver metastases,
b) the delineation of the tumor and c) the determination of local vessel
ingrowth by the tumor.
A more fundamentally oriented objective aims to detect "tumor associated
macrophages" in a pancreatic or periampullary carcinoma with an in vivo 3T
NANO-MRI.

Feasibility study.

Except for the discomfort of lying in an MRI scanner for about 1 hour, MRI
offers no risks for patients without pre-assessed contra-indications (e.g.
metallic implants). The contrast agent ferumoxtran-10 can cause a contrast
reaction during and shortly after administration. Therefore this administration
is performed within the hospital under supervision of qualified personnel.