DCE MRI in Patients With Pancreatic Cancer

NCT02070705 | Terminated DMC

• 6 other identifiers: IRB00009694NCI-2014-00270MR00045736CR00022704K08EB012859U01CA278923
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.

Conditions

Familial Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreatic Intraductal Papillary-Mucinous Neoplasm

Outcome Measures

Primary Outcomes (3)

• Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I)

  Descriptive statistical analysis will be conducted for primary endpoints.

  Up to 5 years

• Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II)

  Descriptive statistical analysis will be conducted for primary endpoints.

  Up to 5 years

• Change in tumor margins in patients who have undergone chemotherapy for pancreatic cancer (Group III)

  The change of dynamic contrast enhanced magnetic resonance imaging (DCE MRI) parameters from baseline will be correlated with the tumor margins determined by pathological specimen following surgical resection through linear regression model.

  Baseline to up to 2 years

Secondary Outcomes (13)

• Disease free survival (Group I)

  Time of enrollment to time of diagnosis, assessed up to 5 years

• Disease free survival (Group II)

  Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years

• Disease free survival (Group III)

  Time of surgical resection to time of recurrence, assessed up to 5 years

• Overall survival (Group I)

  Time of surgical resection to time of death, assessed up to 5 years

• Overall survival (Group II)

  Time of surgical resection to time of death, assessed up to 5 years

Study Arms (4)

Arm I (High-risk for familial/hereditary pancreatic cancer)

EXPERIMENTAL

Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol

Arm II (IPMN)

EXPERIMENTAL

Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol

Arm III (Pancreatic cancer)

EXPERIMENTAL

Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol

Arm IV (Healthy volunteers)

ACTIVE COMPARATOR

Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol

Interventions

Dynamic Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo DCE MRI

Also known as: DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Arm I (High-risk for familial/hereditary pancreatic cancer); Arm II (IPMN); Arm III (Pancreatic cancer); Arm IV (Healthy volunteers)

Ferumoxytol DRUG

Given IV

Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

Arm I (High-risk for familial/hereditary pancreatic cancer); Arm II (IPMN); Arm III (Pancreatic cancer); Arm IV (Healthy volunteers)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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): 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Oregon Health and Science University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pancreatic carcinoma, familial; Pancreatic Intraductal Neoplasms

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Alexander Guimaraes

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: January 31, 2014
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)