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| Name | Class |
|---|---|
| Cancer Intelligence Care Systems, Inc. | INDUSTRY |
| Sumitomo Heavy Industries, Ltd. | UNKNOWN |
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To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.
To evaluate the safety of [18F]FBPA synthesized with MPS200FBPA. In addition, the usefulness of [18F]FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boron Neutron Capture Therapy (BNCT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNCT | Radiation | Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours. Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence rate of dose-limiting toxicity | Baseline until Day180 | |
| RECIST v1.1 | Baseline until Day180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-ku | Osaka | Osaka | 541-0043 | Japan |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| D018319 | Neurofibrosarcoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| [18F]FBPA | Diagnostic Test | Intravenous injection of [18F]FBPA and radiation exposure from PET-CT scan. |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| D005354 | Fibrosarcoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |