NCT04588025 · Ohio State University
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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. Pancreatic Cancer Participants: Inclusion Criteria:
- 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 Criteria:
- 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.
Where
- Columbus, Ohio
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations