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This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CivaSheet Directional LDR Brachytherapy | Experimental | FDA Cleared CivaSheet directional Pd-103 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CivaSheet | Device | implanting CivaSheet for localized radiation dose delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate at 1 year | The local control rate in the region irradiated by CivaSheet. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from regional or distant recurrence | Control rate for recurrences outside the local area irradiated by CivaSheet. | 1 year |
| Time to recurrence | Time in months to any recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 1 year |
| Toxicity graded on CTCAE 4.0 Scale | pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc. | 1 year |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |