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

NCT06612580 | Recruiting Early Phase 1

• 1 other identifier: FAHFJ-68Ga-AAZTA-NI-093
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

PSMA; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events

  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 Outcomes (1)

• Dosimetry data

  through study completion, an average of 3 months

Other Outcomes (1)

• Diagnostic value

  through study completion, an average of 3 months

Study Arms (1)

68Ga-AAZTA-NI-093 PET/ CT

EXPERIMENTAL

68Ga-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

Drug: 68Ga-AAZTA-NI-093

Interventions

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.

68Ga-AAZTA-NI-093 PET/ CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Weibing Miao, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

86-0591-87981618; miaoweibing@126.com

Guochang Wang, MD

CONTACT

86-0591-87981619; guochang1007@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: September 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (1)