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NCT06419361 Clinical Trial

[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients

Cancer Clinical Trial

Official title:
[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06419361
Other study ID # CYYY-KY-2024-049-01
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date May 21, 2024
Est. completion date December 31, 2026

Study information
Verified date May 2024
Source First Affiliated Hospital of Chongqing Medical University
Contact Xiaoyang Zhang, PhD
Phone 023-89011755
Email zhangxy@mail.bnu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist ([68Ga]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. At least 18 years of age. 2. Signed informed consent. 3. Patients with suspected or newly diagnosed or previously malignant disease. Exclusion Criteria: 1. Patients with non-malignant disease. 2. Patients with pregnancy. 3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. 4. Known or expected hypersensitivity to [68Ga]Ga-Sa-DABI-4 or any of its components. 5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• [68Ga]Ga-Sa-DABI-4
Each subject receives a single intravenous injection of [68Ga]Ga-Sa-DABI-4.

Locations
Country Name City State
China The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic efficacy The sensitivity, specificity, and accuracy of [68Ga]Ga-Sa-DABI-4 PET 15 days
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