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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
RECRUITINGSafety evaluation
The number and percentage of patients with adverse events/serious adverse events
Time frame: Within 21 days after administration
Biological distribution
Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images
Time frame: 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
Time frame: 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)
Time frame: through study completion, an average of 3 months
Semi-quantitative analysis
Standard uptake values (SUVmax, SUVmean)
Time frame: 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
Time frame: through study completion, an average of 3 months
Biological distribution
Retention time of each organ of interest through RT01-89Zr PET/CT images
Time frame: through study completion, an average of 3 months
Biological distribution
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Standard uptake value(SUV) of each organ of interest through RT01-89Zr PET/CT images
Time frame: through study completion, an average of 3 months
Semi-quantitative analysis
Target-to-background ratio (TBR) (background can include mediastinum, general background, liver, muscle);
Time frame: through study completion, an average of 3 months