Clinical trial · Interventional
68Ga-P16-093 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients
A Pilot Prospective Comparison of 68Ga-P16-093 and 68Ga-PSMA-617 in the Same Group of Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-P16-093 | Drug | — | UNRESOLVED |
| 68Ga-PSMA-617 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA617 and 68Ga-P16-093 PET/CT scan
- description
- Patients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/CT scan after intravenous administration of 68Ga-PSMA617 and 68Ga-P16-093, respectively.
- interventionNames
- Drug: 68Ga-PSMA-617
- Drug: 68Ga-P16-093
Primary outcomes (1)
- measure
- Metabolic parameters
- timeFrame
- through study completion, an average of 1 year]
- description
- the early dynamic distribution (SUVmax in tumor lesions and SUVmean in normal organs at different time points) of 68Ga-P16-093 in comparison with 68Ga-PSMA-617 in the same group of prostate cancer patients.
Secondary outcomes (2)
- measure
- detection capability of tumor
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * 68Ga-PSMA617 and 68Ga-P16-093 PET/CT within two consecutive days; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
References
Publications (2)
- DERIVEDWang G, Li L, Zang J, Hong H, Zhu L, Kung HF, Zhu Z. Head-to-Head Comparison of 68 Ga-P16-093 and 68 Ga-PSMA-617 PET/CT in Patients With Primary Prostate Cancer : A Pilot Study. Clin Nucl Med. 2023 Apr 1;48(4):289-295. doi: 10.1097/RLU.0000000000004566. Epub 2023 Jan 20. PMID 36727866
- DERIVEDWang G, Hong H, Zang J, Liu Q, Jiang Y, Fan X, Zhu Z, Zhu L, Kung HF. Head-to-head comparison of [68 Ga]Ga-P16-093 and [68 Ga]Ga-PSMA-617 in dynamic PET/CT evaluation of the same group of recurrent prostate cancer patients. Eur J Nucl Med Mol Imaging. 2022 Feb;49(3):1052-1062. doi: 10.1007/s00259-021-05539-1. Epub 2021 Sep 23. PMID 34557930