Insulinoma
Conditions
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.
Interventions
DRUG[68Ga]Ga-HBED-CC-exendin-4
Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) \[68Ga\]Ga-HBED-CC-exendin-4. Tracer doses of \[68Ga\]Ga-HBED-CC-exendin-4 will be used to image lesions of insulinoma by PET/CT.
DRUG[68Ga]Ga-NOTA-exendin-4
Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) \[68Ga\]Ga-NOTA-exendin-4. Tracer doses of \[68Ga\]Ga-NOTA-exendin-4 will be used to image lesions of insulinoma by PET/CT.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* pregnancy; * breastfeeding; * known allergy against exendin-4; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| GLP-1R expression and SUV | through study completion, an average of 1 year | Correlation between GLP-1R expression and SUV in PET |
Countries
China
Outcome results
None listed