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

Chongqing Medical University

Status and phase: Enrolling; Early Phase 1

Conditions: Stimulator of Interferon Gene; Cancer; Positron Emission Tomography

Treatments: Drug: [68Ga]Ga-Sa-DABI-4

Study type: Interventional

Funder types: Other

Identifiers

NCT06419361

CYYY-KY-2024-049-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

[68Ga]Ga-Sa-DABI-4

Experimental group

Description:

Patients will receive a single administration of \[68Ga\]Ga-Sa-DABI-4.

Treatment:

Drug: [68Ga]Ga-Sa-DABI-4