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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT04588025
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Point-of-care Portable Perfusion Phantom, P4 — DEVICE
    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 Details

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.

Key Dates

Start date
Oct 14, 2020
Status verified
Sep 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Healthy Volunteers
  • Active Comparator: Pancreatic Cancer Participants

Primary Outcome Measure

Reproducibility of quantitative DCE-MRI measurement with MRI 1. [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Tamara Stein, MPH
[email protected]
614-293-8315
Harrison Kim, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Seth Smith, PhD
[email protected]
615-322-6211
Junzhong Xu, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
The Ohio State University· Columbus, OHVanderbilt University Medical Center· Nashville, TN

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