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

May 27, 2024 updated by: First Affiliated Hospital of Fujian Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the AAZTA chelator for labeling with 68Ga(III). This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PET/CT in the same group of prostate cancer patients.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-AAZTA-093 PET/ CT
Drug: 68Ga-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.
Drug: 68Ga-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.
Experimental: 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT
Drug: 68Ga-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.
Drug: 68Ga-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation
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.
Within 7 days following PET/CT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry data
Time Frame: through study completion, an average of 3 months
Calculate the absorbed dose of 68Ga-AAZTA-093 in normal organs.
through study completion, an average of 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: through study completion, an average of 3 months
Sensitivity and Specificity of 68Ga-AAZTA-093 for prostate cancer in comparison with 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.
through study completion, an average of 3 months
SUV of tumors
Time Frame: through study completion, an average of 3 months
Compare the SUV of tumors between 68Ga-AAZTA-093 PET/CT and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT.
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstAHFujian-68Ga-AAZTA-093

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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