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RecruitingNCT06419361Updated Jun 4, 2025

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

An Early Phase 1 interventional study of [68Ga]Ga-Sa-DABI-4 in Stimulator of Interferon Gene, Cancer and Positron Emission Tomography, sponsored by First Affiliated Hospital of Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by First Affiliated Hospital of Chongqing Medical University · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 4 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stimulator of Interferon Gene
  • Cancer
  • Positron Emission Tomography
03

In context

Lead sponsor

First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    [68Ga]Ga-Sa-DABI-4

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

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

Interventions

  • Drug[68Ga]Ga-Sa-DABI-4

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

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What researchers measure

Primary outcomes

  1. Diagnostic efficacy

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

    Time frame: 15 days

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400016, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06419361
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible party
Xiaoyang Zhang (Principal Investigator, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
May 17, 2024
Start date
May 30, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 4, 2025

Study contacts

Xiaoyang Zhang, PhD
Contact
zhangxy@mail.bnu.edu.cn
023-89011755

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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