Actively Recruiting
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
Led by Ohio State University · Updated on 2026-02-27
55
Participants Needed
2
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to investigate whether the therapeutic response of pancreatic tumors can be accurately assessed using quantitative DCE-MRI, when the inter/intra-scanner variability is reduced using the Point-of-care Portable Perfusion Phantom, P4. The intra-scanner variability over time leads to errors in therapy monitoring, while the inter-scanner variability impedes the comparison of data among institutes. The P4 is small enough to be imaged concurrently in the bore of a standard MRI scanner with a patient for real-time quality assurance. The P4 is safe, inexpensive and easily operable, thus it has great potential for widespread and routine clinical use for accurate diagnosis, prognosis and therapy monitoring. This study has identified two arms, one arm is healthy individuals that will undergo DCE MRI at three different MRI locations to establish baseline results. The healthy volunteers will undergo these MRIs prior to the second arm, which contains patients with pancreatic cancer. The pancreatic cancer patients will only have DCE MRI done at one location.
CONDITIONS
Official Title
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 19 years of age or older
- All racial and ethnic groups are eligible without exclusion based on race, ethnicity, or gender
- Healthy volunteers must have no known major health problems including cancers, heart diseases, diabetes, high blood pressure, cholesterol issues, stroke, respiratory problems, or arthritis
- Patients must have biopsy-confirmed locally advanced pancreatic cancer
You will not qualify if you...
- Participants with any known major health problems are excluded
- Participants with safety contraindications to MRI examination are excluded
- Participants on hemodialysis or with acute renal failure are excluded due to risks associated with gadolinium contrast
- Participants who are pregnant or lactating are excluded
- Participants who may father a child during the study are excluded
- Participants must have been using an effective form of birth control before starting the study unless unable to have children due to surgery or medical reasons
- Participants must agree to continue effective birth control use for 6 months after the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
H
Harrison Kim, PhD
CONTACT
T
Tamara Stein, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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