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This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Directional Brachytherapy Source Implant | Experimental | Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CivaSheet | Device | The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale | Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale. | 1.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University, Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |