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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special imaging technique called dynamic contrast-enhanced MRI to help detect pancreatic cancer. The goal is to determine if this method can better identify and understand pancreatic cancer or its risk factors. Participants may include those with a strong family history of pancreatic cancer, individuals diagnosed with pancreatic cancer, or healthy volunteers with no significant history of pancreatic disease. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance early detection methods for pancreatic cancer.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are HIV-positive and on antiretroviral therapy, you are not eligible to participate due to potential interactions with the study's contrast agent.

What prior data suggests that this imaging technique is safe for identifying pancreatic cancer?

Research shows that dynamic contrast-enhanced magnetic resonance imaging (DCE MRI) is generally safe for patients. This type of scan uses magnets to capture detailed body images and often employs a special dye, like ferumoxytol, to enhance clarity.

Studies have found that ferumoxytol is safe and well-tolerated in MRI scans. Specifically, research comparing ferumoxytol to other iron-based treatments found it equally safe, with no increase in side effects.

Overall, evidence suggests that DCE MRI, when used with ferumoxytol, is a safe imaging choice, even for individuals with pancreatic conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE MRI) for pancreatic cancer because it offers a novel way to visualize blood flow and tissue characteristics in tumors. Unlike standard imaging techniques, DCE MRI provides more detailed information about tumor vascularity and tissue perfusion, which can help tailor treatment plans. This technique uses a contrast agent called Ferumoxytol, which is different from traditional contrast agents and can offer clearer images, especially in patients with kidney issues. The potential to better assess tumor response to therapies, especially before surgeries, could lead to more personalized and effective treatment strategies.

What evidence suggests that DCE MRI is effective for identifying pancreatic cancer?

Research has shown that a special type of MRI scan, called Dynamic Contrast-Enhanced MRI (DCE MRI), can help detect pancreatic cancer. In this trial, participants will undergo DCE MRI scans to assess its effectiveness in different contexts. Studies have found that DCE MRI effectively examines blood flow and the structure of the pancreas, aiding in early cancer detection. It can also distinguish between pancreatic cancer and other conditions like chronic pancreatitis. In animal studies, DCE MRI demonstrated the ability to monitor tumor response to treatments. This imaging method could enhance the understanding and management of pancreatic cancer. ^{5 6 7 8 9}

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

HEALTHY VOLUNTEERS (Group 4): Must meet inclusion criteria for 'all participants' described above

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

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 of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9914475/

Dynamic Contrast-Enhanced Magnetic Resonance ... The aim of the study was to analyze DCE-MRI perfusion parameters in normal pancreatic parenchymal tissue and PDAC and to evaluate the efficacy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9406679/

DWI Metrics Differentiating Benign Intraductal Papillary ... In conclusion, studies in GEM models demonstrate the potential utility of diffusion-weighted MRI metrics for distinguishing pancreatic cancer ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1007134/full

Multitasking dynamic contrast enhanced magnetic ... Conclusion: Multitasking DCE MRI is a promising clinical tool that is capable of unbiased quantitative differentiation between CP from PDAC.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0730725X15000569

Pancreatic cancer growth using magnetic resonance and ... This paper describes an experimental model of human pancreatic cancer and a related non invasive imaging technique suitable for monitoring tumor growth and ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/25/7/2314/265989/Dynamic-Contrast-enhanced-MRI-Detects-Responses-to

Dynamic Contrast-enhanced MRI Detects Responses to ... Using relevant animal models, this study demonstrated that a quantitative marker derived from dynamic contrast-enhanced MRI can detect early responses to stroma ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02070705

NCT02070705 | DCE MRI in Patients With Pancreatic Cancer This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of ...

7. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct02070705

DCE MRI in Patients With Pancreatic Cancer These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X25002050

Conditions at risk of pancreatic cancer: The radiology ... Their data confirmed the low risk of pancreatic cancer development in patients with BD-IPMN with a 2.9 % incidence of pancreatic cancer; moreover, worrisome ...

9. mdpi.com mdpi.com/2075-4418/13/3/521

Dynamic Contrast-Enhanced Magnetic Resonance ... The aim of the study was to analyze DCE-MRI perfusion parameters in normal pancreatic parenchymal tissue and PDAC and to evaluate the efficacy ...