Clinical Trial · NCT05955677

Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

Overview

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[68Ga\]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68Ga\]Ga-PSMA-11.

Sponsor

Anhui Provincial Hospital

Phase

Early Phase 1

Contacts

Qiang Xie, MD (CONTACT)

xieqiang1980@ustc.edu.cn

+8613721108043

Qiang Xie (STUDY_CHAIR)

ClinicalTrials.gov

NCT05955677

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

PSMA-D5

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
  • simultaneous \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 examinations within two weeks;
  • Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
  • Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);

Exclusion

  • Other circumstances deemed by the investigator to be inappropriate for trial participation.
  • Patients with liver and kidney dysfunction;
  • Concurrent malignant tumors;
  • Previous alcohol allergy;
  • Patients who cannot cooperate with the examination;