DCE MRI for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Antiretrovirals

Disqualifiers: Multiple allergies, Iron metabolism diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 years

77 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Alexander Guimaraes

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals at high risk of pancreatic cancer, those with confirmed pancreatic adenocarcinoma, and healthy volunteers without a history of cancer. Participants must be able to consent and women of childbearing potential need a negative pregnancy test. Exclusions include allergies to iron products, certain health conditions like hemochromatosis or renal insufficiency, HIV patients on specific treatments, and anyone unable to undergo MRI.

Inclusion Criteria

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

I am at high risk for pancreatic cancer due to my family history or genetic condition.

I have been diagnosed with pancreatic cancer and may or may not need chemotherapy before surgery.

Exclusion Criteria

You have allergies to multiple drugs or have had allergic reactions to intravenous iron replacement products.

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.)

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo DCE MRI to assess the presence and characteristics of pancreatic cancer

Varies by group

1-3 visits (in-person)

Treatment

Participants in Arm III may undergo chemotherapy prior to surgical resection

Up to 2 years

Follow-up

Participants are monitored for disease-free and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Contrast-Enhanced Magnetic Resonance Imaging
• Ferumoxytol

Trial Overview The study tests DCE MRI's ability to identify pancreatic cancer by taking detailed images using magnetic fields. It involves people at high risk for the disease, those who may have it already or are undergoing chemotherapy, as well as healthy controls for comparison.

How Is the Trial Designed?

Group I: Arm III (Pancreatic cancer) Experimental Treatment 2 Interventions

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.

Group II: Arm II (IPMN) Experimental Treatment 2 Interventions

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

Group III: Arm I (High-risk for familial/hereditary pancreatic cancer) Experimental Treatment 2 Interventions

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

Group IV: Arm IV (Healthy volunteers) Active Control 2 Interventions

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

Dynamic Contrast-Enhanced Magnetic Resonance Imaging is already approved in United States, European Union for the following indications:

Approved in United States as Y-90 SIRT for:

• Primary liver cancer (HCC)
• Metastatic colorectal cancer (liver metastases)

Approved in European Union as Y-90 SIRT for:

• Primary liver cancer (HCC)
• Metastatic colorectal cancer (liver metastases)

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

1

Recruited

80+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+