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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06419361
Enrollment
30
Registered
2024-05-17
Start date
2024-05-30
Completion date
2026-12-31
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Positron Emission Tomography, Stimulator of Interferon Gene

Brief 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.

Interventions

DRUG[68Ga]Ga-Sa-DABI-4

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

Sponsors

First Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic efficacy15 daysThe sensitivity, specificity, and accuracy of \[68Ga\]Ga-Sa-DABI-4 PET

Countries

China

Contacts

Primary ContactXiaoyang Zhang, PhD
zhangxy@mail.bnu.edu.cn023-89011755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026