RecruitingEarly Phase 1NCT06437496

68Ga-AAZTA-093 PET/CT: First-in-human Study

68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • confirmed treated or untreated prostate cancer patients;
  • Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week;
  • signed written consent.

Exclusion Criteria2

  • known allergy against PSMA;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Interventions

DRUG68Ga-AAZTA-093

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT.

DRUG68Ga-PSMA-11//68Ga-PSMA-617

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11//68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.


Locations(1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT06437496


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