An interventional study of 18F-N230A in Renal Cell Carcinoma (RCC) and Renal Pelvic Urothelial Carcinoma, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Diagnostic
Renal cell carcinoma and renal pelvic urothelial carcinoma are common malignant tumors of the urinary system. Accurate preoperative differentiation between these tumor types is important for treatment planning, while conventional imaging methods may have limitations in characterizing tumor biology.
Nectin-4 is a tumor-associated molecular target that is highly expressed in several epithelial malignancies, particularly urothelial carcinoma. 18F-N230A is a novel PET imaging probe targeting Nectin-4. This study aims to evaluate the safety, biodistribution, and imaging characteristics of 18F-N230A PET/CT in patients with suspected or confirmed renal tumors.
Participants enrolled in this study will undergo 18F-N230A PET/CT imaging and 18F-FDG PET/CT imaging. The imaging findings and quantitative parameters will be analyzed and compared. Pathological results obtained from surgery or biopsy will be used as the reference standard to evaluate the potential value of 18F-N230A PET/CT in differentiating renal cell carcinoma from renal pelvic urothelial carcinoma.
This study may provide a new molecular imaging approach for improving the preoperative diagnosis of renal tumors and supporting individualized clinical decision-making.
1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.
This study's planned enrollment of 80 is above the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.
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Participants with suspected or confirmed renal tumors will receive an intravenous injection of 18F-N230A followed by PET/CT imaging. Participants will also undergo 18F-FDG PET/CT imaging for comparison. PET/CT imaging findings will be analyzed and compared with pathological results obtained from surgery or biopsy to evaluate the diagnostic value of 18F-N230A PET/CT for differentiating renal cell carcinoma and renal pelvic urothelial carcinoma.
Drug: 18F-N230A
18F-N230A is a Nectin-4-targeting PET radiopharmaceutical. Participants will receive intravenous administration of 18F-N230A followed by PET/CT imaging to evaluate Nectin-4 expression in renal tumors.
Diagnostic Accuracy of 18F-N230A PET/CT
Diagnostic accuracy will be calculated as the percentage of patients correctly classified as having renal cell carcinoma or renal pelvic urothelial carcinoma by 18F-N230A PET/CT, using histopathological findings from surgery or biopsy as the reference standard. Diagnostic accuracy will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
Time frame: Up to 2 months after PET/CT imaging
Sensitivity of 18F-N230A PET/CT for Detecting Renal Pelvic Urothelial Carcinoma
Sensitivity will be calculated as the percentage of patients with histopathologically confirmed renal pelvic urothelial carcinoma correctly identified by 18F-N230A PET/CT. Histopathological findings from surgery or biopsy will serve as the reference standard. Sensitivity will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
Time frame: Up to 2 months after PET/CT imaging
Specificity of 18F-N230A PET/CT for Detecting Renal Pelvic Urothelial Carcinoma
Specificity will be calculated as the percentage of patients with histopathologically confirmed renal cell carcinoma correctly classified as negative for renal pelvic urothelial carcinoma by 18F-N230A PET/CT. Histopathological findings from surgery or biopsy will serve as the reference standard. Specificity will be compared with that of 18F-FDG PET/CT. Results will be expressed as percentages.
Time frame: Up to 2 months after PET/CT imaging
Maximum Standardized Uptake Value (SUVmax) of Renal Lesions
The maximum standardized uptake value (SUVmax) will be measured within renal tumor lesions on 18F-N230A PET/CT and 18F-FDG PET/CT images. SUVmax represents the highest standardized radiotracer uptake within the tumor lesion. Values will be reported separately for each imaging modality as unitless standardized uptake values.
Time frame: At the time of PET/CT imaging
Mean Standardized Uptake Value (SUVmean) of Renal Lesions
The mean standardized uptake value (SUVmean) will be measured within renal tumor lesions on 18F-N230A PET/CT and 18F-FDG PET/CT images. SUVmean represents the average standardized radiotracer uptake within the tumor lesion. Values will be reported separately for each imaging modality as unitless standardized uptake values.
Time frame: At the time of PET/CT imaging
Lesion-to-Liver Background Uptake Ratio on PET/CT
The lesion-to-liver background uptake ratio will be calculated by dividing the maximum standardized uptake value (SUVmax) of the renal tumor lesion by the mean standardized uptake value (SUVmean) measured in a reference region of normal liver tissue. The ratio will be calculated separately for 18F-N230A PET/CT and 18F-FDG PET/CT. Results will be reported as unitless ratios.
Time frame: At the time of PET/CT imaging
Lesion-to-Mediastinal Blood Pool Uptake Ratio on PET/CT
The lesion-to-mediastinal blood pool uptake ratio will be calculated by dividing the maximum standardized uptake value (SUVmax) of the renal tumor lesion by the mean standardized uptake value (SUVmean) measured in the mediastinal blood pool reference region. The ratio will be calculated separately for 18F-N230A PET/CT and 18F-FDG PET/CT. Results will be reported as unitless ratios.
Time frame: At the time of PET/CT imaging
Lesion-to-Muscle Uptake Ratio on PET/CT
The lesion-to-muscle uptake ratio will be calculated by dividing the maximum standardized uptake value (SUVmax) of the renal tumor lesion by the mean standardized uptake value (SUVmean) measured in a reference muscle region. The ratio will be calculated separately for 18F-N230A PET/CT and 18F-FDG PET/CT. Results will be reported as unitless ratios.
Time frame: At the time of PET/CT imaging
Plan to share: No
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Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 108 non-industry interventional studies with no phase under Carcinoma, Renal Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 128. This study's planned 29 months is below that.
Counting every sponsor, half of 115 studies reached it within 48 months; a quarter within 21 and three quarters within 128.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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