Recruiting

DCE-MRI

Sponsor:

Ohio State University

Code:

NCT04588025

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Point-of-care Portable Perfusion Phantom, P4

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Study ID

NCT04588025

Start date

Oct 14, 2020

Status verified date

Sep, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Healthy Volunteers

active comparator: Pancreatic Cancer Participants

Interventions

Point-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.

Primary outcome measure

  • Reproducibility of quantitative DCE-MRI measurement with MRI 1. [ Time Frame: Baseline ]
  • Reproducibility of quantitative DCE-MRI measurement with MRI 2. [ Time Frame: Baseline to 3-days (MRI number 2) ]
  • Reproducibility of quantitative DCE-MRI measurement with MRI 3. [ Time Frame: Baseline to 7-days (MRI number 3) ]
  • Measure change in blood flow within the pancreatic cancer as measured by the P4. [ Time Frame: Baseline ]
  • Measure change in blood flow within the pancreatic cancer as measured by the P4. [ Time Frame: 6 weeks post-therapy ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Harrison Kim, PhD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Junzhong Xu, PhD

More Information

Sponsor

Ohio State University

Last update posted

Feb 27, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-27.