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Recruiting NCT06419361

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

Early Phase I Interventional Stimulator of Interferon Gene Cancer Positron Emission Tomography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-Sa-DABI-4.
Who it may be relevant to
Registry conditions: Stimulator of Interferon Gene, Cancer, Positron Emission Tomography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Diagnostic efficacy [Time frame: 15 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT06419361 · CYYY-KY-2024-049-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗