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

NCT ID: NCT05034783

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-06-01

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.

Conditions

Insulinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan

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.

Group Type: EXPERIMENTAL

[68Ga]Ga-HBED-CC-exendin-4

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

[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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

[68Ga]Ga-HBED-CC-exendin-4 injection; [68Ga]Ga-NOTA-exendin-4 injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Li L, Wang G, Wang J, Ma H, Chen J, Wang R, Pan Q, Hong H, Jin W, Kung HF, Zhu L, Luo Y, Zhu Z. Glucagon-Like Peptide-1 Receptor-Targeted PET/CT With 68 Ga-HBED-CC-Exendin-4 in Localizing Insulinoma : A Head-to-Head Comparison to 68 Ga-NOTA-Exendin-4. Clin Nucl Med. 2025 Jan 1;50(1):38-43. doi: 10.1097/RLU.0000000000005533. Epub 2024 Nov 8.

Reference Type: DERIVED

PMID: 39499011 (View on PubMed)

Other Identifiers

PUMCH-NM-EX4

Identifier Type: -

Identifier Source: org_study_id