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To evaluate the safety of 18F-LNC1007 injection in the diagnosis of suspected tumor, initial stage, or recurrence monitoring; to explore the biological distribution of 18F-LNC1007 injection in patients; To compare the diagnostic efficacy of 18F-LNC1007 injection PET/CT versus 18F-FDG PET/CT imaging in patients with tumor with clinical suspicion, initial stage, or recurrence monitoring.
This is a prospective, controlled, open-label (with blind members), single-center clinical trial to evaluate the diagnostic efficacy and safety of 18F-LNC1007 injection PET/CT for suspected tumor or tumor initial staging, recurrence monitoring, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compare 18F-LNC1007 injection (18F-FAPI-RGD) PET/CT and 18F-FDG PET/CT imaging | This is a prospective, controlled, open-label (with blind members), single-center clinical trial to evaluate the diagnostic efficacy and safety of 18F-LNC1007 injection PET/CT for suspected tumor or tumor initial staging, recurrence monitoring, etc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-LNC1007(18F-FAPI-RGD) PET/CT和18F-FDG PET/CT | Other | Eligible subjects will receive 18F-LNC1007 (18F-FAPI-RGD) PET/CT and 18F-FDG PET/CT examinations within 1 week (the interval between the two examinations shall not exceed 7 days, and the scanning parameters, scanning range, image reconstruction methods, etc., shall be consistent). That is, with 18F-LNC1007 (18F-FAPI-RGD) PET/CT time as D0, 18F-FDG PET/CT examination can accept data from D1 to D7 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT; | To evaluate the sensitivity and specificity of 18F-LNC1007 (18F-FAPI-RGD) PET/CT at the patient level compared with 18F-FDG PET/CT; | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases | Compare the difference of the uptake of imaging agent between 18F-LNC1007 (18F-FAPI-RGD) and 18F-FDG injection in tumor lesions or metastases | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The type, incidence, and severity of adverse events were graded using the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI CTCAE) V5.0 standard | The type, incidence, and severity of adverse events were graded using the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI CTCAE) V5.0 standard | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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A patient with a clinically suspected or confirmed tumor
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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