Application of 68Ga-labeled ACE2 Targeting Probe PET/CT Imaging in Tracing ACE2 Expression and Diagnosis of Lung Cancer

Lung Cancer Clinical Trial

Official title:

Application of 68Ga-labeled ACE2 Targeting Probe PET/CT Imaging in Tracing ACE2 Expression and Diagnosis of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194630
• Other study ID #: PekingUMCH ACE2 68Ga-A3
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 30, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: 13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the past three years, as the key protein suggested to be involved in host cell entry of SARS-CoV-2, studies of ACE2 aroused people's attention again. Tracking the expression of ACE2 in vivo is crucial to further understanding of COVID-19, dynamically monitoring the effect of antiviral therapy and the development of related vaccines. It is also expected to further conduct in-depth research on the physiological effects of ACE2 and RAAS, and the mechanism of ACEI/ARB (32). With the development of both molecular imaging agents and related equipment, several ACE2-targeting PET imaging agents have been investigated based on different strategies while some of them were tested in clinical trials. The aim of this study was to intercept key ACE2-binding sites from coronavirus RBD and test their potential as ACE2-targeting PET agents.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2025
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• the ability to provide informed written consent

• a medical history without any ACE2-related comorbidities

Exclusion Criteria:

• liver and renal function dysfunction,

• pregnancy or current lactation

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 68Ga-A3
Intravenous injection of 68Ga-A3 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-A3 will be used to image organs or lesions which expresses ACE2 by PET/CT.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science	Beijing
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standardized uptake value (SUV)	comparing the SUVmean of different organs or lesions	through study completion, an average of 1 year
Secondary	Diagnostic performance	evaluating the number of lung cancer lesions detected by 68Ga-A3	through study completion, an average of 1 year