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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Positron Emission Tomography; Stimulator of Interferon Gene
• Intervention / Treatment: Drug: [68Ga]Ga-Sa-DABI-4

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyang Zhang, PhD; Phone Number: 023-89011755; Email: zhangxy@mail.bnu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Xiaoyang Zhang, PhD; Phone Number: 023-89011755; Email: zhangxy@mail.bnu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [68Ga]Ga-Sa-DABI-4; Patients will receive a single administration of [68Ga]Ga-Sa-DABI-4.	Drug: [68Ga]Ga-Sa-DABI-4; Each subject receives a single intravenous injection of [68Ga]Ga-Sa-DABI-4.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CYYY-KY-2024-049-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No