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Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization

RecruitingNAAges 18 Years - 70 YearsAllPeking Union Medical College Hospital
NCT07808879 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical research evaluates a new PET/CT imaging agent, \[68Ga\]Ga-HBED-CC-PEG6-exendin-4, for localizing insulinoma, a rare pancreatic tumor that causes severe low blood sugar. Insulinomas are often small and hard to detect with regular CT, ultrasound or standard PET scans. This new tracer targets GLP1R, a protein highly expressed on insulinoma cells, with polyethylene glycol (PEG6) modification to improve tumor uptake and image contrast compared with the earlier similar agent \[68Ga\]Ga-HBED-CC-exendin-4. The investigators plan to enroll 20 adult patients suspected of or confirmed to have insulinoma. All participants will receive two free PET/CT scans within one week: one with the new PEG6-modified tracer and one with the original tracer. The first 3 participants will also get dynamic PET scanning to analyze drug distribution and radiation dose in the human body. Within one month

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 70 years, male or female. 2. Clinically suspected insulinoma with biochemically proven endogenous hyperinsulinism. 3. Complete clinical information and conventional abdominal imaging data available. 4. Scheduled for pancreatic surgery or biopsy within 30 days after PET/CT examination for pathological confirmation. 5. Capable of completing two GLP-1R-targeted PET/CT scans within a 7-day interval. 6. Voluntarily provides written informed consent and cooperates with study procedures. Exclusion Criteria: 1. Pregnancy, suspected pregnancy, or lactating status. 2. Severe hepatic or renal dysfunction prohibiting radiotracer injection. 3. Known allergy or hypersensitivity to exendin-4, gallium-based tracers, or injection excipients. 4. Uncontrolled severe systemic diseases that preclude PET/CT acquisition.
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What it tests

  • [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT
  • [68Ga]Ga-HBED-CC-exendin-4 PET/CT
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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