drugset / Trial / NCT05324332
68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients
NaSingle-groupOpen-labelDiagnostic
Summary
Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68Ga-PSMA-11. This pilot study was evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.
Timeline
- Start
- 2022-04-15
- Primary completion
- 2025-01-01
- Completion
- 2025-12-31
Publications
- Wang J, Li L, Chen J, Wang R, Xiang J, Peng X, Wang Y, Luo Y, Zhu L, Kung HF, Zhou Z, Xiao Y, Zhu Z. [68Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [68Ga]Ga-PSMA-11. Eur J Nucl Med Mol Imaging. 2026 Apr;53(5):3064-3073. doi: 10.1007/s00259-025-07687-0. Epub 2025 Dec 10.
- Wang G, Li L, Zhu M, Zang J, Wang J, Wang R, Yan W, Zhu L, Kung HF, Zhu Z. A prospective head-to-head comparison of [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT in patients with primary prostate cancer. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3126-3136. doi: 10.1007/s00259-023-06283-4. Epub 2023 May 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-P16-093 | Diagnostic / imaging agent | 1.8 mbq/kg | Intravenous |
| Subject | 68Ga-P16-093 | Diagnostic / imaging agent | 2.2 mbq/kg | Intravenous |
| Subject | 68Ga-PSMA-11 | Diagnostic / imaging agent | 1.8 mbq/kg | Intravenous |
| Subject | 68Ga-PSMA-11 | Diagnostic / imaging agent | 2.2 mbq/kg | Intravenous |