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RecruitingNCT04588025Updated Feb 27, 2026

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

An interventional study of Point-of-care Portable Perfusion Phantom, P4 in Pancreatic Cancer, sponsored by Ohio State University. Recruiting at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Ohio State University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2020; still recruiting 5 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 55 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Healthy Volunteer - a small number of healthy volunteers (5) will be used as the control group.

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Active comparator
    Healthy Volunteers

    Device: Point-of-care Portable Perfusion Phantom, P4

  • Active comparator
    Pancreatic Cancer Participants

    Device: Point-of-care Portable Perfusion Phantom, P4

Interventions

  • DevicePoint-of-care Portable Perfusion Phantom, P4

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline to 3-days (MRI number 2)

  3. 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.

    Time frame: Baseline to 7-days (MRI number 3)

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: 6 weeks post-therapy

07

Study locations

2 of 2 sites recruiting
  • The Ohio State University
    Columbus, Ohio 43210, United States
    • Tamara Stein, MPH · Contact · Tamara.Stein@osumc.edu · 614-293-8315
    • Harrison Kim, PhD · Principal investigator
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    • Seth Smith, PhD · Contact · seth.smith@vumc.org · 615-322-6211
    • Junzhong Xu, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — To be determined

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04588025
Lead sponsor
Ohio State University
Responsible party
Harrison Kim (Professor, Ohio State University) — Principal investigator
First posted
Oct 19, 2020
Start date
Oct 14, 2020
Primary completion
Oct 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Harrison Kim, PhD
Contact
Harrison.Kim@osumc.edu
614-293-8315
Tamara Stein, MPH
Contact
Tamara.Stein@osumc.edu
614-293-8315
Harrison Kim, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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