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NCT Number: NCT06612580

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

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.

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Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location status: Recruiting

About this study

Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-NI-093 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in prostate cancer patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed treated or untreated prostate cancer patients;
  • signed written consent.

Exclusion criteria

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

Treatment and study plan

68Ga-AAZTA-NI-093

Drug

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.

Primary outcomes

  1. Adverse events

    Time frame: Within 7 days following PET/CT

    The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

Secondary outcomes

  1. Dosimetry data

    Time frame: through study completion, an average of 3 months

    Calculate the absorbed dose of 68Ga-AAZTA-NI-093 in normal organs.

Other outcomes

  1. Diagnostic value

    Time frame: through study completion, an average of 3 months

    Sensitivity and Specificity of 68Ga-AAZTA-NI-093 for prostate cancer in comparison with 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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