Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID06419361

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

Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-06-04

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the stimulator of interferon gene (STING) protein, which plays an important role in the immune system's ability to detect tumors. This trial focuses on evaluating a new imaging agent called [68Ga]Ga-Sa-DABI-4, designed to noninvasively detect STING expression in the tumor environment using positron emission tomography (PET). The study aims to assess the safety, distribution in the body, and potential usefulness of this imaging agent for cancer patients. Participants will receive one intravenous injection of the investigational drug [68Ga]Ga-Sa-DABI-4 during the study. This single administration is followed by PET imaging to monitor how the agent interacts with the tumor. The study is conducted in an early phase 1 design, focusing on initial safety and diagnostic capabilities. During the trial, participants will undergo PET scans to evaluate the diagnostic effectiveness of the imaging agent within 15 days after injection. Researchers will monitor safety and how the drug distributes throughout the body. The study includes patients suspected of having or newly diagnosed with malignant diseases. Participation involves a single dosing and imaging session, with safety and diagnostic data collected during this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Signed informed consent
  • Patients with suspected, newly diagnosed, or previous malignant disease
Not Eligible

You will not qualify if you...

  • Patients with non-malignant disease
  • Patients who are pregnant
  • Inability or unwillingness to provide written informed consent
  • Known or expected hypersensitivity to [68Ga]Ga-Sa-DABI-4 or its components
  • Any serious medical condition or circumstance that may interfere with study procedures or evaluations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants receive a single intravenous injection of [68Ga]Ga-Sa-DABI-4 followed by PET imaging to assess stimulator of interferon gene expression in cancer.

1 visit (in-person)

Long-term Monitoring

Duration - 15 days

Participants are monitored for up to 15 days to evaluate diagnostic efficacy and any related outcomes.

Follow-up contact(s) as needed

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400016

Actively Recruiting

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Research Team

X

Xiaoyang Zhang, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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