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NCT Number: NCT06419361

[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.

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Key information

Conditions

Stimulator of Interferon Gene Cancer Neoplasms Positron Emission Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Xiaoyang Zhang, PhD

CONTACT

[email protected]

023-89011755

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age.
  • Signed informed consent.
  • Patients with suspected or newly diagnosed or previously malignant disease.

Exclusion criteria

  • Patients with non-malignant disease.
  • Patients with pregnancy.
  • The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
  • Known or expected hypersensitivity to [68Ga]Ga-Sa-DABI-4 or any of its components.
  • Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Treatment and study plan

[68Ga]Ga-Sa-DABI-4

Drug

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

Primary outcomes

  1. Diagnostic efficacy

    Time frame: 15 days

    The sensitivity, specificity, and accuracy of [68Ga]Ga-Sa-DABI-4 PET

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyang Zhang, PhD

CONTACT

[email protected]

023-89011755

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 17, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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