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Clinical Trials in China / NCT06756334
Recruiting Phase EARLY_PHASE1

Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis

NCT06756334 · tracked via the Priya Life Science China tracker
Sponsor
Anhui Provincial Hospital
Phase
Phase EARLY_PHASE1
Started
2024-12-19
Last updated
2025-01-03

Condition(s) studied

Prostate CancerPET/CT

Investigational drug(s) / intervention(s)

[18F]AlF-PSMA-N5[18F]F-DCFPyL

[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.

[18F]F-DCFPyL: Each subject receive a single intravenous injection of \[18F\]F-DCFPyL, and undergo PET/CT imaging within the specificed time.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital) Hefei Anhui Recruiting

More Anhui Provincial Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06756334 on ClinicalTrials.gov ↗ ← All trials in China