NCT06194630

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P50-P75 for early_phase_1 lung-cancer

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

January 8, 2024

Status Verified

November 1, 2023

Enrollment Period

12 days

First QC Date

December 22, 2023

Last Update Submit

December 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • standardized uptake value (SUV)

    comparing the SUVmean of different organs or lesions

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Diagnostic performance

    through study completion, an average of 1 year

Study Arms (1)

68Ga-A3

EXPERIMENTAL

Within 1 week, each participant underwent PET/CT scan after intravenous administration of 68Ga-A3

Drug: 68Ga-A3

Interventions

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.

68Ga-A3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the ability to provide informed written consent
  • a medical history without any ACE2-related comorbidities

You may not qualify if:

  • liver and renal function dysfunction,
  • pregnancy or current lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science

Beijing, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

November 30, 2023

Primary Completion

December 12, 2023

Study Completion

November 30, 2025

Last Updated

January 8, 2024

Record last verified: 2023-11

Locations