[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients

Insulinoma Clinical Trial

Official title:

A Pilot Prospective Comparison of [68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05034783
• Other study ID #: PUMCH-NM-EX4
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: October 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulinoma

Intervention

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.
• [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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GLP-1R expression and SUV	Correlation between GLP-1R expression and SUV in PET	through study completion, an average of 1 year
Primary	Metabolic parameters	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.	through study completion, an average of 1 year
Secondary	Diagnostic value	Sensitivity and Specificity of [68Ga]Ga-HBED-CC-exendin-4 for insulinoma in comparison with [68Ga]Ga-NOTA-exendin-4 PET/CT.	through study completion, an average of 1 year