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Cedars-Sinai Cancer Center Protocol Review and Monitoring Committee has requested several protocol modifications and clarifications regarding study outcomes and completion of data entry for subjects who exited the study. Changes are in the process.
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The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).
The overarching goal of this pilot study is to evaluate the usefulness of a novel Magnetic Resonance Imaging (MRI) approach, which measure properties of tumor microenvironment (i.e. vascularity, fibrosis), to predict PDAC response to neoadjuvant therapy (NAT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6D-MRI | Experimental | Participants will undergo 6D-MRI imaging three times throughout the course of the study: once pre-NAT treatment, once during NAT treatment, and once post-NAT treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6D-MRI | Diagnostic Test | Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of progression-free survival from baseline | Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging. | 2 years |
| Number of participants with R0 resection | The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Pandol, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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