研究目的
To evaluate the safety, whole-body distribution, dose estimation, and lesion accumulation of 18F-FSU-880, a newly developed probe targeting prostate-specific membrane antigen in prostate cancer patients.
研究成果
PET/CT with 18F-FSU-880 was safely conducted and effectively visualized active metastatic lesions with high image contrast. The effective dose was acceptable. The results support further clinical studies with larger cohorts to confirm utility in prostate cancer management.
研究不足
The study had a small sample size of only six patients, which limits the generalizability of the findings. Not all suspected lesions were confirmed due to the primary focus on safety evaluation. The effect of treatments on probe uptake could not be fully elucidated. Potential for physiological fluctuations in blood/urine data may affect interpretation.
1:Experimental Design and Method Selection:
A first-in-man clinical study involving six prostate cancer patients with known metastatic lesions. Serial whole-body PET/CT scans were performed using 18F-FSU-
2:Biodistribution, safety, and dosimetry were assessed. Sample Selection and Data Sources:
8 Patients aged 20-85 years with known metastatic lesions were included, excluding those with poor general condition or severe renal dysfunction. Data from blood, urine, and PET/CT images were collected.
3:List of Experimental Equipment and Materials:
PET/CT scanner (Discovery IQ; GE Healthcare), automated synthesis module (COSMiC-Compact 24XX; NMP Business Support Company), γ-counter for radioactivity counting, OLINDA/EXM software for dosimetry calculations.
4:Experimental Procedures and Operational Workflow:
Patients fasted for >4 hours before the study. After vital sign evaluation, low-dose CT was performed for attenuation correction. 18F-FSU-880 was administered intravenously, and serial PET scans were conducted at multiple time points. Blood and urine samples were collected before, during, and after PET/CT for safety and biodistribution analysis.
5:Data Analysis Methods:
PET images were reconstructed using an ordered subset expectation maximization algorithm with CT-attenuation correction. Standardized uptake values (SUVmean and SUVmax) were measured for organs and lesions. Tumor-to-blood ratios were calculated. Radiation dosimetry was performed using OLINDA/EXM software.
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