← Back to Search

DCE MRI for Pancreatic Cancer

N/A
Recruiting
Led By Alexander Guimaraes
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 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 3 participants must have pathologically- confirmed pancreatic adenocarcinoma, with or without the need for neoadjuvant chemotherapy prior to surgical resection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am at high risk for pancreatic cancer due to my family history or genetic condition.
Select...
I have been diagnosed with pancreatic cancer and may or may not need chemotherapy before surgery.
Select...
I have never had cancer, pancreatic disease, or a family history of pancreatic cancer.
Select...
I have IPMN and my scans show I need surgery based on symptoms or scan results.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
7%
Headache
5%
Chest pain - cardiac
5%
Dehydration
5%
Infection and infestations - other
5%
Back pain
5%
Myocardial infarction
2%
Seizure
2%
Chest wall pain
2%
Hypoxia
2%
Vascular disorder - other
2%
Thromboembolic event
2%
Syncope
2%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Cediranib Maleate)

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
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
2006
Completed Phase 2
~310
Ferumoxytol
2011
Completed Phase 4
~4380

Find a Location

Who is running the clinical trial?

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
88 Previous Clinical Trials
19,624 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
967 Previous Clinical Trials
6,845,576 Total Patients Enrolled
National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK)UNKNOWN

Media Library

Dynamic Contrast-Enhanced Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT02070705 — N/A
Pancreatic Cancer Research Study Groups: Arm III (Pancreatic cancer), Arm I (High-risk for familial/hereditary pancreatic cancer), Arm IV (Healthy volunteers), Arm II (IPMN)
Pancreatic Cancer Clinical Trial 2023: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT02070705 — N/A
Dynamic Contrast-Enhanced Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT02070705 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor accept subjects that are 45 years and older?

"According to the eligibility requirements of this trial, any patient aged 18-85 is able to participate."

Answered by AI

What are the projected results of this research?

"The primary aim of this medical trial, with an expected duration of up to 5 years, is to determine the presence or lack thereof of pancreatic cancer in patients suffering from cystic lesions. Secondary objectives include evaluating disease-free survival through Kaplan-Meier analysis and overall survival along with surgical diagnostic measures using AJCC TNM staging system as potential confounders or modifiers for the model. The c-statistics will be reported on each model."

Answered by AI

Are there any prior experiments that have employed Dynamic Contrast-Enhanced Magnetic Resonance Imaging?

"Currently, 15 clinical trials are researching the application of Dynamic Contrast-Enhanced Magnetic Resonance Imaging. Of those, 4 have reached Phase 3. Moreover, 40 different sites across New york are running studies on this diagnostic imaging technology."

Answered by AI

What is the aggregate quantity of participants involved in this research project?

"Indeed, the clinical trial is actively enrolling participants as suggested by its listing on clinicaltrials.gov. This research project was initially posted January 31st 2014 and has been updated once since then, on August 16th 2022. They are looking for 70 individuals to join at one dedicated site of study."

Answered by AI

Am I eligible to participate in this experiment?

"This medical investigation is searching for 70 volunteers aged 18 to 85 who have been diagnosed with pancreatic carcinoma. Additionally, they must satisfy the following conditions: possess a high-risk genetic syndrome (e.g., BRCA 1&2, STK11, CDNK2A, PRSS1 and MSH 2&6), GROUPS 1, 2 AND 3 participants must qualify for surgical resection based on conventional imaging findings or symptoms; all volunteers are required to undertake a negative pregnancy test if applicable; consenting to join the Oregon Pancreatic Tumor Registry (OPTR) is mandatory; those with strong"

Answered by AI

Is acceptance into this medical study still possible for interested participants?

"Yes, clinicaltrials.gov indicates that the trial is still recruiting applicants. It was initially posted in January 2014 and last edited in August 2022; with a goal of enlisting 70 patients from 1 site."

Answered by AI
~7 spots leftby Dec 2024