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Improving Pancreatic Cancer MRI Measurements with P4

This study is testing a new device called the Point-of-care Portable Perfusion Phantom (P4) to see if it can make MRI scans for pancreatic cancer more accurate. Currently, there can be differences in MRI results over time or between different MRI machines, which makes it harder to track how well treatments are working. The P4 is a small device that can be scanned at the same time as a patient to help make sure the MRI results are consistent. We want to see if using the P4 can lead to more reliable measurements of how pancreatic tumors respond to treatment. This study is looking for 55 participants, including a small number of healthy volunteers, who are 19 years or older and do not have major health problems. The study's success will be measured by how consistently the quantitative DCE-MRI (Dynamic Contrast Enhanced-MRI, a type of MRI that shows blood flow) measurements are reproduced over time.

Study design
This study is an interventional study with an estimated enrollment of 55 participants, including 5 healthy volunteers as a control group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures reproducibility of MRI measurements at baseline, up to 3 days later, and up to 7 days later.

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NCT04588025

Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response

Recruiting
NAAges 19+InterventionalDiagnostic
Ohio State University
~55 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Point-of-care Portable Perfusion Phantom, P4

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reproducibility of quantitative DCE-MRI measurement with MRI 1.
Measured over Baseline
+4 more outcomes measured

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

2 sites across 2 states
Ohio1
Tennessee1

Study leadership

  • Harrison Kim, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Harrison Kim, PhD
[email protected]
614-293-8315
Email the study team

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Eligibility criteria

Inclusion

Targeted/planned enrollment in the study will include all racial/ethnic groups with no groups excluded on the basis of race, ethnicity or gender.
Participants should be 19 years of age or older
Participants should not have any known major health problems including but not limited to cancers, heart diseases, diabetes, high blood pressure and/or cholesterol, stroke, respiratory problems, and arthritis.
Patients having biopsy proven locally advanced pancreatic cancer will be asked to participate in this study.
Targeted/planned enrollment in the study will include all racial/ethnic groups, with no groups excluded on the basis of race, ethnicity or gender.
Participants should be 19 years of age or older.

Exclusion

Participants having any known major health problems will be excluded.
Participants with safety contraindications to MRI examination (determined by standard clinical screening).
Participants on hemodialysis or with acute renal failure will be excluded. (Participants on hemodialysis and those with renal failure who receive intravenous gadolinium may be at increased risk for a condition called Nephrogenic systemic fibrosis/ Nephrogenic fibrosing dystrophy and thus will be excluded.)
Participants may not be pregnant or lactating.
Participants may not father a child while on this study as the treatment may indirectly affect an unborn child.
Unless participants cannot have children because of surgery or other medical reasons, participants must have been using an effective form of birth control before starting the study.
Participants must also agree to continue to use an effective form of birth control for 6 months after taking the study. Effective birth control includes birth control pills, patch, IUD (intrauterine device), condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy.
Participants with safety contraindications to MRI examination (determined by standard clinical screening).
Participants on hemodialysis or with acute renal failure will be excluded.
Participants on hemodialysis and those with renal failure who receive intravenous gadolinium may be at increased risk for a condition called Nephrogenic systemic fibrosis/ Nephrogenic fibrosing dystrophy and thus will be excluded.
Participants may not be pregnant or lactating.
Participants may not father a child while on this study as the treatment may indirectly affect an unborn child.
Unless participants cannot have children because of surgery or other medical reasons, participants must have been using an effective form of birth control before starting the study.
Participants must also agree to continue to use an effective form of birth control for 6 months after taking the study. Effective birth control includes birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy.

What this trial measures

  • Reproducibility of quantitative DCE-MRI measurement with MRI 1.Baseline

    This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs. Two scans will be done to establish baseline measures.

  • Reproducibility of quantitative DCE-MRI measurement with MRI 2.Baseline to 3-days (MRI number 2)

    This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.

  • Reproducibility of quantitative DCE-MRI measurement with MRI 3.Baseline to 7-days (MRI number 3)

    This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.

  • Measure change in blood flow within the pancreatic cancer as measured by the P4.Baseline

    This is being done before therapy has been initiated and is being measured by the P4 during an MRI scan. The results will help determine if undergoing therapy is effective by measuring the change in blood flow and help to decide if we need to continue the current therapy or change to a different one. Blood flow often serves as a critical indicator showing a disease status.

  • Measure change in blood flow within the pancreatic cancer as measured by the P4.6 weeks post-therapy

    This is being done after therapy has been initiated and is being measured by the P4 during an MRI scan. The results will help determine if undergoing therapy is effective by measuring the change in blood flow and help to decide if we need to continue the current therapy or change to a different one. Blood flow often serves as a critical indicator showing a disease status.