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

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new radioactive imaging agent called 68Ga-AAZTA-093 that targets a protein called PSMA (found on prostate cancer cells) to see how it compares to the standard PSMA imaging scan in detecting prostate cancer using a PET/CT scan. **You may be eligible if...** - You have been diagnosed with prostate cancer (treated or untreated) - You are able to have both the new imaging scan (68Ga-AAZTA-093) and a standard PSMA PET/CT scan within one week of each other - You are willing to sign informed consent **You may NOT be eligible if...** - You have a known allergy to PSMA - You have a medical condition that might significantly interfere with the study in your doctor's opinion 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-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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