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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Stimulator of Interferon Gene Cancer Positron Emission Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[68Ga]Ga-Sa-DABI-4

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

Group Type EXPERIMENTAL

[68Ga]Ga-Sa-DABI-4

Intervention Type DRUG

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

Interventions

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[68Ga]Ga-Sa-DABI-4

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes