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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 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

ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 5 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Pancreatic Cancer
Pancreatic Neoplasm
Pancreatic Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

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

Select...

Group 3 participants must have been diagnosed with pancreatic cancer, confirmed by a pathology test, and may or may not have received chemotherapy before surgery.

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

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

Headache

Back pain

Chest pain - cardiac

Infection and infestations - other

Dehydration

Myocardial infarction

Seizure

Chest wall pain

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

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

2006

Completed Phase 2

~310

Ferumoxytol

2011

Completed Phase 4

~4380

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH

86 Previous Clinical Trials

19,143 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

951 Previous Clinical Trials

6,833,763 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 ms; 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

Recent research and studies

clinicaltrials.govStudy

DCE MRI in Patients With Pancreatic Cancer

Alexander Guimaraes 2014. "DCE MRI in Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02070705.

All > Pancreatic Cancer