NCT04588025Recruiting
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 7 Oct 2020
- Start date
- 14 Oct 2020
- Primary completion date
- Oct 2026
- Lead sponsor
- Ohio State University
- Diseases
- Pancreatic cancer
- NCT number
- NCT04588025
What you commit to
- Study type: Interventional
- Planned participants: 55
- From 14 Oct 2020 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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 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:
- 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.
Other
- Participants having any known major health problems will be excluded.
- Participants with safety contraindications to MRI examination (determined by standard clinical screening).
- 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.
- Participants with safety contraindications to MRI examination (determined by standard clinical screening).
- 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.
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- Healthy Volunteer - a small number of healthy volunteers (5) will be used as the control group.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.