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DCE MRI for Pancreatic Cancer

N/A

Waitlist Available

Led By Erin Gilbert

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at using magnetic resonance imaging (MRI) to better identify pancreatic cancer in high risk patients or patients who have undergone chemotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects mainly relate to ferumoxytol used in imaging: allergic reactions similar to other intravenous iron products. There might also be risks associated with gadolinium-based contrast agents used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have never had cancer, pancreatic disease, or a family history of pancreatic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have been diagnosed with or suspected to have a condition related to iron overload.

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I have liver disease, heart issues, or bronzing of the skin.

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I am HIV-positive and not on antiretroviral therapy.

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I cannot have gadolinium-based contrast agents due to health reasons.

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I need anesthesia to undergo an MRI scan.

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My kidney function is reduced with a GFR less than 60 ml/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

DCE- MRI imaging parameters (Group I)

DCE- MRI imaging parameters (Group II)

DCE- MRI imaging parameters (Group III)

+10 more

Side effects data

From 2013 Phase 2 trial • 44 Patients • NCT00227760

11%

Dyspnea

Headache

Infection and infestations - other

Back pain

Chest pain - cardiac

Dehydration

Myocardial infarction

Chest wall pain

Seizure

Hypoxia

Vascular disorder - other

Thromboembolic event

Syncope

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Cediranib Maleate)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (Pancreatic cancer)Experimental Treatment2 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 Treatment2 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 Treatment2 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 Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferumoxytol

2011