Pancreatic CancerNCT04588025
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
A study testing Point-of-care Portable Perfusion Phantom, P4 in people with Pancreatic Cancer, run by Ohio State University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Point-of-care Portable Perfusion Phantom, P4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2020to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Tamara Stein, MPH, 614-293-8315, Tamara.Stein@osumc.edu
Harrison Kim, PhD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Seth Smith, PhD, 615-322-6211, seth.smith@vumc.org
Junzhong Xu, PhD
About this study
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
- Pancreatic Cancer
- Being tested
- Point-of-care Portable Perfusion Phantom, P4
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care Portable Perfusion Phantom, P4Device
P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | Not described Receives: Device: Point-of-care Portable Perfusion Phantom, P4 |
| Pancreatic Cancer Participants | Active comparator | Not described Receives: Device: Point-of-care Portable Perfusion Phantom, P4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of quantitative DCE-MRI measurement with MRI 1.
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.
Measured: Baseline
Reproducibility of quantitative DCE-MRI measurement with MRI 2.
This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.
Measured: Baseline to 3-days (MRI number 2)
Reproducibility of quantitative DCE-MRI measurement with MRI 3.
This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.
Measured: Baseline to 7-days (MRI number 3)
Measure change in blood flow within the pancreatic cancer as measured by the P4.
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.
Measured: Baseline
Measure change in blood flow within the pancreatic cancer as measured by the P4.
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.
Measured: 6 weeks post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start14 Oct 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The healthy group is going to be the group to establish a baseline for the pancreatic group.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrison Kim, Ohio State University
- Investigators
- Harrison Kim, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588025
- Sponsor's protocol ID
- STUDY20250536
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
- ClinicalTrials.gov ID
- NCT04588025
- Acronym / sponsor ID
- STUDY20250536
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The healthy group is going to be the group to establish a baseline for the pancreatic group.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Device: Point-of-care Portable Perfusion Phantom, P4 |
| Pancreatic Cancer Participants | Active comparator | Device: Point-of-care Portable Perfusion Phantom, P4 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care Portable Perfusion Phantom, P4P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners. | Device | Healthy Volunteers, Pancreatic Cancer Participants |
Primary outcome
Reproducibility of quantitative DCE-MRI measurement with MRI 1.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harrison Kim, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care Portable Perfusion Phantom, P4 in people with Pancreatic Cancer, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harrison Kim, PhD (614-293-8315, Harrison.Kim@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of quantitative DCE-MRI measurement with MRI 1. (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.