Clinical trial · Interventional
Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
NCT06756334CI-TRIAL-00084325recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-DCFPyL.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PET/CT | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]AlF-PSMA-N5 | Drug | — | UNRESOLVED |
| [18F]F-DCFPyL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan
- description
- Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL.
- interventionNames
- Drug: [18F]AlF-PSMA-N5
- Drug: [18F]F-DCFPyL
Primary outcomes (1)
- measure
- Standard uptake value(SUV)
- timeFrame
- 30 days
- description
- Standard uptake value(SUV) of \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL for each target lesion of subjects.
Secondary outcomes (2)
- measure
- Diagnostic efficacy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Aged from 18 to 90 years old; * Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.); * Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment; * simultaneous \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL examinations within two weeks; * Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment; * Sign informed consent. Exclusion Criteria: * Patients who cannot cooperate with the examination; * Concurrent malignant tumors; * Previous alcohol allergy; * Patients with liver and kidney dysfunction; * Other circumstances deemed by the investigator to be inappropriate for trial participation.
References
Publications (0)
Data not yet available
No reference posted for this study.