RecruitingEarly Phase 1NCT06756334

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


Sponsor

Anhui Provincial Hospital

Enrollment

30 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

Interventions

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.


Locations(1)

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

Hefei, Anhui, China

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NCT06756334


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