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Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:Preoperative injection of NC527-X | Experimental | This study will set up four single-arm dose groups (A, B, C, D), and it will be conducted in patients with solid tumors who have been diagnosed and are scheduled for surgical resection (evaluated by the researchers to have no surgical contraindications). The study will initially assign patients to groups A, B, C, and D respectively, with each group planning to include at least 3 cases, and a total of no more than 100 cases will be enrolled. The dosages will be 0.005 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.04 mg/kg, and the imaging time window after administration will be 24 to 72 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental:Preoperative injection of NC527-X | Drug | This study will set up four single-arm dose groups (A, B, C, D), and it will be conducted in patients with solid tumors who have been diagnosed and are scheduled for surgical resection (evaluated by the researchers to have no surgical contraindications). The study will initially assign patients to groups A, B, C, and D respectively, with each group planning to include at least 3 cases, and a total of no more than 100 cases will be enrolled. The dosages will be 0.005 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.04 mg/kg, and the imaging time window after administration will be 24 to 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-Background Ratio (SBR) | Signal-to-Background Ratio (SBR): The ratio of the average signal intensity of the target area (tumor) to the average signal intensity of the background tissue. | From the 1st to the 3rd day after administration |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangdong Cheng Cheng | Contact | 0086-571-881280 | Chengxd516@126.com | |
| Can Hu Hu | Contact | 13968032995 | chengxd@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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