[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients
- Conditions
- Insulinoma
- Interventions
- Drug: [68Ga]Ga-NOTA-exendin-4
- Registration Number
- NCT05034783
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
Glucagon-like peptide-1 receptor (GLP-1R)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect insulinoma, like the widely studied \[68Ga\]Ga-NOTA-exendin-4. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, which was compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.
- Detailed Description
Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adult patients without diabetes. The only curative treatment of an insulinoma is its surgical removal. Therefore, exact preoperative localization of the insulinoma is critical to planning the surgical intervention. MR imaging, CT, or endoscopic ultrasound is normally used to localize insulinomas. However, the small size of the tumors (often,1 cm) limits the sensitivity of these methods. In recent years, a new receptor-targeted imaging technique, glucagon-like peptide-1 receptor (GLP-1R) imaging, for detecting insulinoma has been established. GLP-1R is expressed on benign insulinoma cell surfaces with very high incidence (\>90%) and density (8,133 dpm/mg of tissue). No other peptide receptor has been found to exhibit such high expression levels in insulinoma. \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga in order to In order to reduce the accumulation of radioactivity in the kidneys. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4 compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of Insulinoma patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- confirmed treated or untreated insulinoma patients;
- [68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT within two consecutive days;
- signed written consent.
- pregnancy;
- breastfeeding;
- known allergy against exendin-4;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan [68Ga]Ga-NOTA-exendin-4 Patients of Insulinoma PET/CT imaging: In two consecutive days each patient underwent a 60-min dynamic PET/CT scan after intravenous administration of \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4, respectively. [68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan [68Ga]Ga-HBED-CC-exendin-4 Patients of Insulinoma PET/CT imaging: In two consecutive days each patient underwent a 60-min dynamic PET/CT scan after intravenous administration of \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4, respectively.
- Primary Outcome Measures
Name Time Method Metabolic parameters through study completion, an average of 1 year the early dynamic distribution (SUVmax in tumor lesions and SUVmean in normal organs at different time points) of \[68Ga\]Ga-HBED-CC-exendin-4 in comparison with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.
- Secondary Outcome Measures
Name Time Method Diagnostic value through study completion, an average of 1 year Sensitivity and Specificity of \[68Ga\]Ga-HBED-CC-exendin-4 for insulinoma in comparison with \[68Ga\]Ga-NOTA-exendin-4 PET/CT.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China