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

Malignant Neoplasm of Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06437496
• Other study ID #: FirstAHFujian-68Ga-AAZTA-093
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Weibing Miao, MD
• Phone: 86-0591-87981618
• Email: miaoweibing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm of Prostate
• Neoplasms
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic value	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
Other	SUV of tumors	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
Primary	Safety evaluation	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	Dosimetry data	Calculate the absorbed dose of 68Ga-AAZTA-093 in normal organs.	through study completion, an average of 3 months