Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT02070705
Eligibility Criteria:
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, and MSH 2\&6)
* GROUPS 1, 2, AND 3: Group 2 participants identified as having IPMN on standard radiographic imaging that meets criteria for resection based on symptoms or on conventional imaging (computed tomography \[CT\] or MRI) findings
* GROUPS 1, 2, AND 3: Group 3 participants must have pathologically- confirmed pancreatic adenocarcinoma, with or without 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. (For patients that are eligible but there is a concern of metal in their bodies, the will be given the option if interested to have a x-ray completed prior to study enrollment to determine if they can proceed with the study MRI. Patients with a concern of metal in their bodies that don't agree to a x-ray will not be enrolled into the study.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02070705
Study Brief:
Protocol Section:
NCT02070705