Eligibility Details:
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
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
