Point-of-care Portable Perfusion Phantom, P4
DeviceP4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
NCT Number: NCT04588025
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
The Ohio State University, Columbus, Ohio, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Healthy Volunteer - a small number of healthy volunteers (5) will be used as the control group.
Inclusion criteria
Exclusion criteria
Pancreatic Cancer Participants:
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Harrison Kim, PhD
CONTACT
Tamara Stein, MPH
CONTACT
Ohio State University
Other
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