MR-guided biopsy of liver metastases in patients with suspected pancreatic cancer

CECT, mostly used in the diagnostic workup of pancreatic cancer, is probably
insufficient for detecting liver metastases, especially subcentimeter lesions.
With CE-DW-MRI we can possibly improve detection of liver metastases, improving
staging of pancreatic cancer. As most of these lesions are not visible on
transabdominal ultrasound, it is not possible to obtain a histopathologic
biopsy in all patients in order to prove the presence of liver metastases.
Demonstration of liver metastases is of the utmost importance because their
presence precludes a curative resection of the pancreatic tumor and will change
the treatment plan towards palliative chemotherapy. Therefore we want to
perform a MR-guided biopsy, as the next minimal invasive step, to obtain
histopathologic proof of liver metastases.

To obtain histopathology from liver lesions, visible on MRI but which cannot be
biopsied with transabdominal ultrasound, using MR-guided biopsy.

A pilot feasibility study with 20 patients with suspected pancreatic cancer and
suspect liver lesions on CE-DW-MRI. Patients in which the suspect liver lesions
cannot be biopsied with transabdominal ultrasound a MR-guided biopsy will be
performed. This procedure will be performed in the Medical Innovation &
Technology expert Center (MITec), a state-of-the-art centre in the surgical
complex with an MRI-suite where MR-guided interventions can be performed in an
controlled environment next to 2 operating rooms. In the MITeC a MRI of the
liver is performed to localize the liver lesion(s). After local anaesthesia a
liver lesion is biopsied. During the biopsy procedure new MR images are
acquired to guide the needle exactly towards the liver lesion. Preferably two
lesions will be biopsied. After the procedure the intraprocedural MR images
will be evaluated by an independent radiologist, he will determine if the
biopsy location is representative of the lesion location. This radiologist will
be blinded for the outcome of the histopathology. The biopsy specimens are
routinely histopathologically analyzed for the presence of metastasis.

The first 5 patients will be used to determine the technical feasibility of the
technique. The 15 following patients will be used to validate and analyze the
method.

Patients eligible for this study have suspicious liver lesions on MRI which
cannot be biopsied with ultrasound guided biopsy. By participating in this
study we attempt to obtain representative histopathology through MR-guided
biopsy. Hereby patients might benefit from participation because detection of
liver metastases precludes an unnecessary pancreas resection with its
associated morbidity and mortality. This will prevent surgery related loss of
quality of life in the limited life expectancy of patients with metastatic
disease. Furthermore, chemotherapy can start timely, without delay because of
recovery from surgery. Patients will undergo a MRI scan of the liver in the
MITeC to guide the liver biopsy procedure, which will be performed under local
anaesthesia. Preferably two liver lesions will be biopsied. The risks of
MR-guided biopsy are comparable to a routine ultrasound guided biopsy. It is
justified to conduct the study in this patient group, because it cannot be
conducted without the participation of subjects with pancreatic cancer and
suspicious liver lesions on MRI.