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RT01-89Zr is a TF-targeting radiopharmaceutical diagnostic agent. This trial aims to evaluate the safety, biodistribution, dosimetry, and imaging characteristics of RT01-89Zr as a PET/CT tracer in patients with malignant solid tumors that highly express the TF target.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT01-89Zr | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT01-89Zr | Drug | Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | The number and percentage of patients with adverse events/serious adverse events | Within 21 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Biological distribution | Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images | through study completion, an average of 3 months |
| Radiation Dosimetry | Calculate the radiation-absorbed dose of each organ and lesion and the whole-body effective dose using the MIRD method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingchun Yu | Contact | 0510-68089404 | ycjwxd1978@jiangnan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangnan University | Recruiting | Wuxi | Jiangsu | 214122 | China |
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| through study completion, an average of 3 months |
| Visual Analysis | Image visual score 0-3 (0 no obvious uptake, 1 slightly above background, 2 above background, 3 significantly above background) | through study completion, an average of 3 months |
| Semi-quantitative analysis | Standard uptake values (SUVmax, SUVmean) | through study completion, an average of 3 months |
| Probe Targeting Performance Analysis | The sensitivity (positive rate) of RT01-89Zr PET/CT in patients with solid tumors | through study completion, an average of 3 months |
| Biological distribution | Retention time of each organ of interest through RT01-89Zr PET/CT images | through study completion, an average of 3 months |
| Biological distribution | Standard uptake value(SUV) of each organ of interest through RT01-89Zr PET/CT images | through study completion, an average of 3 months |
| Semi-quantitative analysis | Target-to-background ratio (TBR) (background can include mediastinum, general background, liver, muscle); | through study completion, an average of 3 months |