DCE MRI in Patients With Pancreatic Cancer

PRIMARY OBJECTIVES:

I. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients at
high risk for hereditary pancreatic cancer.

II. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients
with cystic lesions of the pancreas.

III. Assess the ability of DCE-MRI to accurately characterize tumor margins in patients who
have undergone chemotherapy or chemoradiotherapy for pancreatic cancer.

IV. Establish baseline DCE-MR imaging parameters of the normal, non-diseased pancreas for use
as a comparator to affected pancreata.

SECONDARY OBJECTIVES:

I. Clinical factors associated with the presence of pancreatic cancer will be assessed in
each of the three experimental groups, including disease free survival and overall survival
will be calculated for each experimental group.

OUTLINE: Patients are assigned to 1 of 4 groups.

ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI
yearly for a minimum of 3 scans.

ARM II (Intraductal papillary mucinous neoplasms [IPMN]): Patients undergo DCE MRI prior to
surgery for resection of IPMN.

ARM III (Pancreatic cancer): Patients undergo DCE MRI before and after receiving neoadjuvant
therapy for borderline or locally advanced pancreatic cancer.

ARM IV (Healthy volunteers): Patients undergo a single DCE MRI examination.

Inclusion Criteria:

- ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing
potential

- ALL PARTICIPANTS: Ability to understand and the willingness to sign a written informed
consent document

- GROUPS 1, 2, AND 3: "All participants" described above

- GROUPS 1, 2, AND 3: Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)

- GROUPS 1, 2, AND 3: Group 1: participants identified as being high-risk for familial
or hereditary pancreatic cancer, and must conform to one or more of the following
requirements:

- Have a strong family history of pancreatic cancer; this is defined as pancreatic
cancer occurring in one first- degree relative and two other relatives, or two
first- degree relatives; or,

- Have a known high-risk genetic syndrome (e.g., BRCA 1&2, STK11, CDNK2A, PRSS1,
MSH 2&6, etc...)

- GROUPS 1, 2, AND 3: Group 2 participants identified as having IPMN on standard
radiographic (computed tomography [CT] or magnetic resonance imaging [MRI]) imaging
that meets criteria for resection based on symptoms or on imaging findings

- GROUPS 1, 2, AND 3: Group 3 participants must have pathologically- confirmed
pancreatic adenocarcinoma and have been determined to have the need for neoadjuvant
chemotherapy prior to surgical resection

- HEALTHY VOLUNTEERS (Group 4): Must meet inclusion criteria for "all participants"
described above

- HEALTHY VOLUNTEERS (Group 4): Group 4 participants must have no history of cancer,
pancreatic disease, or family history of pancreatic cancer

- Family history will be defined as pancreatic cancer occurring in one first-degree
relative and two other relatives, or two first-degree relatives

Exclusion Criteria:

- Participants unable or unwilling to give written, informed consent or to undergo MRI
imaging

- Participants with multiple drug allergies, and/or subjects who have had an allergic
reaction to any intravenous iron replacement product, or a known history of
hypersensitivity to ferumoxytol

- Participants with concurrent clinical diagnosis, evidence of suspected
hemochromatosis, or other diseases of iron metabolism (i.e., iron overload)

- Cirrhosis, cardiomyopathy, restrictive heart disease, or bronzing of the skin

- Pregnant women are excluded from this study because there is an unknown, but potential
risk, for adverse events, as small animal trials have linked ferumoxytol
administration (at very high doses) to birth defects (e.g., soft-tissue malformations
and decreased fetal weights); it is not known whether ferumoxytol is present in human
milk; breastfeeding, however, should be discontinued if the mother receives
ferumoxytol while nursing

- Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral
therapy are ineligible because of the potential for pharmacokinetic interactions with
ferumoxytol

- Participants with diagnosis of renal insufficiency or glomerular filtration rate (GFR)
< 60 ml/min/1.73m^2

- Adult patients who require monitored anesthesia for MRI scanning

- Participants with any contraindications to gadolinium-based contrast agents

- Participants who have a contraindication for MRI (e.g. metal in their bodies, a
cardiac pacemaker, or other incompatible device), or are severely agitated or
claustrophobic