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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Active Comparator |
| |
| Pancreatic Cancer Participants | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 6 weeks post-therapy |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harrison Kim, PhD | Contact | 614-293-8315 | Harrison.Kim@osumc.edu | |
| Tamara Stein, MPH | Contact | 614-293-8315 | Tamara.Stein@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Harrison Kim, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
To be determined
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The healthy group is going to be the group to establish a baseline for the pancreatic group.
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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