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Trial Title:
[68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients
NCT ID:
NCT06419361
Condition:
Stimulator of Interferon Gene
Cancer
Positron Emission Tomography
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-Sa-DABI-4
Description:
Each subject receives a single intravenous injection of [68Ga]Ga-Sa-DABI-4.
Arm group label:
[68Ga]Ga-Sa-DABI-4
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Start date:
May 21, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
First Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Chongqing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06419361
