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Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval
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The purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. This study will test magnetic resonance techniques on FDA approved clinical MRI machines in treatment-naïve patients with biopsy-proven PDAC.
Specific Aims
The investigators hypothesize the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Naïve PDAC Patients | Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion) |
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| Measure | Description | Time Frame |
|---|---|---|
| Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC) | Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis). | Study Duration, an average of 1 year |
| Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC | Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis). | Study Duration, an average of 1 year |
| Correlate MRI biomarkers with histopathology (the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response). | Biomarkers are obtained from the following imaging methods: Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis). | Study Duration, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Leo L Tsai, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
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| Label | URL |
|---|---|
| Key Statistics for Pancreatic Cancer | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |