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

NCT07808879 | Recruiting

• 2 other identifiers: 68Ga-HBED-CC-PEG6-exendin-42025-PUMCH-D-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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 after imaging, patients will undergo surgery or biopsy to get pathological results, which serve as the gold standard to calculate and compare the diagnostic accuracy of the two tracers. All imaging procedures follow standard clinical protocols with safe, low radiation doses within national diagnostic limits. Minor possible risks include slight pain or mild allergic reaction at the injection site; rare side effects related to exendin-4 may occur at a rate below 5%, and the research team has full emergency management measures ready. Participants can withdraw from the study at any time without penalty. All scan fees are covered by the research project, and each subject will receive a formal imaging report for clinical reference. The findings of this trial will help develop a more accurate imaging tool to precisely locate insulinoma and guide surgical treatment.

Conditions

Insulinoma

Keywords

insulinoma; GLP-1R; PET/CT; exendin-4

Outcome Measures

Primary Outcomes (5)

• Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization

  sensitivity of \[68Ga\]Ga-HBED-CC-PEG6-exendin-4 and \[68Ga\]Ga-HBED-CC-exendin-4 PET/CT.

  Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results

• Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization

  specificity of \[68Ga\]Ga-HBED-CC-PEG6-exendin-4 and \[68Ga\]Ga-HBED-CC-exendin-4 PET/CT.

  Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results

• Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization

  accuracy of \[68Ga\]Ga-HBED-CC-PEG6-exendin-4 and \[68Ga\]Ga-HBED-CC-exendin-4 PET/CT.

  Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results

• Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization

  PPV of \[68Ga\]Ga-HBED-CC-PEG6-exendin-4 and \[68Ga\]Ga-HBED-CC-exendin-4 PET/CT.

  Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results

• Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization

  NPV of \[68Ga\]Ga-HBED-CC-PEG6-exendin-4 and \[68Ga\]Ga-HBED-CC-exendin-4 PET/CT.

  Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results

Secondary Outcomes (4)

• Comparison of tumor-to-background ratios of the two GLP-1R radiotracers

  Within 2 months after completion of two PET/CT scans and pathological confirmation

• Comparison of renal uptake of the two GLP-1R radiotracers

  Within 2 months after completion of two PET/CT scans and pathological confirmation

• Area under plasma radioactivity concentration-time curve (AUC0-t)

  Within 2 months after dynamic PET acquisition of the first three subjects

• Internal radiation dosimetry of [68Ga]Ga-HBED-CC-PEG6-exendin-4

  Within 2 months after dynamic PET acquisition of the first three subjects

Study Arms (1)

Single Arm: Dual PET/CT Imaging with [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4

EXPERIMENTAL

All enrolled subjects receive two PET/CT scans within a 7-day interval at no cost. The first scan uses the investigational radiotracer \[68Ga\]Ga-HBED-CC-PEG6-exendin-4, and the second scan uses the reference tracer \[68Ga\]Ga-HBED-CC-exendin-4, or vice versa. The first 3 participants will additionally undergo dynamic PET/CT acquisition to calculate human pharmacokinetic parameters and internal radiation dosimetry. Baseline clinical history, laboratory tests and prior imaging data are collected before tracer injection. All subjects will receive surgical resection or biopsy within 30 days after imaging to obtain histopathological results as the reference standard. Two independent nuclear medicine physicians perform blinded visual and semi-quantitative analysis of all PET/CT images to compare the diagnostic performance of the two GLP-1R-targeted radiotracers for insulinoma localization.

Diagnostic Test: [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT; Diagnostic Test: [68Ga]Ga-HBED-CC-exendin-4 PET/CT

Interventions

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

Investigational GLP-1R-targeted radiopharmaceutical modified with a PEG6 linker. Synthesized under mild 50 °C, 5 min one-step radiolabeling without purification, with radiochemical purity \>95% for up to two half-lives. Intravenous dose 1-4 mCi for whole-body PET/CT. The first 3 enrolled subjects receive dynamic PET acquisition to calculate human pharmacokinetic profiles and internal organ radiation dosimetry. Preclinical data confirmed elevated pancreatic and insulinoma uptake and improved pancreas-to-kidney ratio compared with non-PEGylated reference tracer.

Also known as: 68Ga-HBED-CC-PEG6-exendin-4

Single Arm: Dual PET/CT Imaging with [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4

[68Ga]Ga-HBED-CC-exendin-4 PET/CT DIAGNOSTIC_TEST

Reference GLP-1R-targeted radiopharmaceutical without PEG6 modification, serving as the control agent for head-to-head comparison. Prepared via one-step mild radiolabeling with no purification needed. Intravenous injection of 1-4 mCi followed by standard static PET/CT, completed within 7 days before or after the investigational tracer scan in each subject. Exhibits relatively higher renal background uptake that may interfere with visualization of left peri-renal insulinoma lesions. No dynamic PET acquisition is performed for this reference tracer.

Also known as: 68Ga-HBED-CC-exendin-4

Single Arm: Dual PET/CT Imaging with [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years, male or female.
• Clinically suspected insulinoma with biochemically proven endogenous hyperinsulinism.
• Complete clinical information and conventional abdominal imaging data available.
• Scheduled for pancreatic surgery or biopsy within 30 days after PET/CT examination for pathological confirmation.
• Capable of completing two GLP-1R-targeted PET/CT scans within a 7-day interval.
• Voluntarily provides written informed consent and cooperates with study procedures.

You may not qualify if:

• Pregnancy, suspected pregnancy, or lactating status.
• Severe hepatic or renal dysfunction prohibiting radiotracer injection.
• Known allergy or hypersensitivity to exendin-4, gallium-based tracers, or injection excipients.
• Uncontrolled severe systemic diseases that preclude PET/CT acquisition.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yaping Luo, MD

CONTACT

86-10-69154717; luoyaping@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)