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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm RT: HIFU plus ThermoDox | Experimental | Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose. |
|
| Arm NRT: HIFU plus ThermoDox | Experimental | Subjects have no yet received any radiation to the index lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete pain response | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Borys, M.D. | Imunon | Study Director |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D000230 | Adenocarcinoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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