NCT06756334

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

\[18F\]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18F\]F-DCFPyL PET/CT.

Conditions

• Prostate Cancer
• PET/CT

Interventions

Type	Name	Description
DRUG	[18F]AlF-PSMA-N5	Each subject receive a single intravenous injection of \[18F\]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time.
DRUG	[18F]F-DCFPyL	Each subject receive a single intravenous injection of \[18F\]F-DCFPyL, and undergo PET/CT imaging within the specificed time.

Timeline

• Start date: 2024-12-19
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2025-01-03
• Last updated: 2025-01-03

Locations

1 site across 1 country: China