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Clinical Trials in China / NCT06756334
Recruiting Early Phase 1

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
Early Phase 1
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)

  • Standard uptake value(SUV) — 30 days
    Standard uptake value(SUV) of \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL for each target lesion of subjects.

Trial sites (1)

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

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Other trials for the same condition

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Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis Recruiting
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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