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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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At present there is no validated prognostic tool for patients with resectable pancreatic cancer (RPC) to determine how best to tailor individual therapy. This study is to see if tumor features in blood and imaging prior to surgery correspond with tumor heterogeneity in the specimen after surgery.
This study is to prospectively determine whether there is a predictive relationship in RPC between pre-operative radiomic imaging features and pathologic tumor heterogeneity, delineated by gene-expression-based RSI and histologic measures of hypoxia measured by Glut-1 and CA-IX as well as the degree of pimonidazole staining.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scans, Surgical Resection and Assessment | Experimental | Pre-surgery scans, surgical resection and post-surgery pathological assessment. All patients will receive standard of care imaging and blood tests. If suitable, non-standard of care abdominal MRI imaging will be done. 16-24 hours prior to surgery, patients will be administered a single dose of 0.5 g/m^2 pimonidazole (HydroxyProbe). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimonidazole | Drug | Patients will take a single dose of 0.5 g/m^2 (approximately 13 mg/kg) of oral pimonidazole HCI 16 to 24 hours prior to surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiosensitivity Index and Degree of Pimonidazole Staining | Relationship between PET/CT, MRI or pancreas protocol CT features and the pathological correlations of radiation sensitivity and hypoxia, as measured by the radiosensitivity index (RSI) and degree of pimonidazole staining in resectable pancreatic cancer. | Up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Correlative Biomarkers | Investigators will quantitiatively compare correlative biomarkers with the degree of pimonidazole staining and RSI. These biomarkers will include radiomic features from the preoperative imaging tests, serum CA 19-9, and histological markers for biological hypoxia, GLUT-1, and CA-IX. Data from all of these biomarkers will be available as continuous variables. The association between RSI (or % pimonidazole-positive pixels) and biomarkers will be assessed using the Spearman correlation analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Hoffe, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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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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| ID | Term |
|---|---|
| C033815 | pimonidazole |
| D016577 | Pancreaticoduodenectomy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
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| Surgical Resection | Procedure | Patients will undergo Pancreaticoduodenectomy or Whipple procedure, which involves the resection of the pancreatic head, duodenum, gallbladder, and a portion of the stomach, 16 to 24 hours after consuming oral pimonidazole. |
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| Up to 14 weeks |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |