RecruitingEarly Phase 1NCT06612580

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

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

Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

10 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Adenocarcinoma)

Summary

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

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new PET imaging agent called 68Ga-AAZTA-NI-093, which is designed to detect prostate-specific membrane antigen (PSMA) — a protein found on prostate cancer cells. The scan could help doctors better locate prostate cancer and plan treatment. **You may be eligible if...** - You have confirmed prostate cancer (treated or untreated) - You are able to provide written informed consent **You may NOT be eligible if...** - You have a known allergy to PSMA-targeting agents - You have another medical condition that the study doctor believes would significantly affect your participation or safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-AAZTA-NI-093

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

Locations(1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT06612580

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