InsulinomaHBED-CC-PEG6-ENCT07808879
Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization
A study testing [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT and [68Ga]Ga-HBED-CC-exendin-4 PET/CT in people with Insulinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insulinoma
- What is being tested?
- [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT and [68Ga]Ga-HBED-CC-exendin-4 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiling Lin, 86-10-69154187, xs@abscd.com
About this study
Official title: [68Ga]Ga-HBED-CC-PEG6-Exendin-4 PET/CT Imaging in the Diagnosis of Insulinoma
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.
Read the detailed description
Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adults. Most lesions are benign but typically small (1-2 cm), leading to poor detection sensitivity for conventional cross-sectional imaging including abdominal ultrasound and routine CT, which frequently fails to pinpoint tiny tumor foci. Incomplete resection results in persistent hypoglycemic symptoms and poor quality of life, creating an urgent clinical demand for sensitive, noninvasive localization modalities.
Glucagon-like peptide-1 receptor (GLP-1R) is abundantly overexpressed on benign insulinoma cells at levels approximately five times higher than normal pancreatic beta cells, making it an ideal molecular target for positron emission tomography. Earlier GLP-1R-targeted radiotracers such as [68Ga]Ga-NOTA-exendin-4 require high-temperature heating and post-labeling purification, limiting routine clinical deployment. The precursor probe [68Ga]Ga-HBED-CC-exendin-4 can be synthesized under mild conditions without purification but still presents relatively high physiological renal uptake that may obscure lesions adjacent to the kidney.
To further optimize pharmacokinetic behavior, a PEG6 linker was conjugated to the HBED-CC-exendin-4 scaffold to generate the novel radiotracer [68Ga]Ga-HBED-CC-PEG6-exendin-4. Preclinical mouse biodistribution and microPET experiments demonstrated significantly higher pancreatic and insulinoma tumor uptake, longer intralesional tracer retention, and an improved pancreas-to-kidney ratio relative to the non-PEGylated counterpart, which is expected to enhance lesion conspicuity on clinical PET/CT. Competitive blocking assays verified that tumor signal originates from specific GLP-1R binding. This novel radiopharmaceutical meets compendial standards for sterility and bacterial endotoxin and maintains high radiochemical purity for two physical half-lives after formulation.
This single-center prospective comparative trial will recruit 20 subjects aged 18-70 years with suspected or pathologically verifiable insulinoma. Eligible participants complete two radiotracer PET/CT examinations within a 7-day window at no personal cost: one using the PEG6-modified investigational agent and one using the original [68Ga]Ga-HBED-CC-exendin-4 reference tracer. The initial three enrolled subjects additionally undergo dynamic PET acquisition to generate human pharmacokinetic parameters and internal radiation dosimetry estimates. Baseline laboratory tests, clinical history, and prior imaging data are collected before radiotracer injection. All participants receive surgical resection or biopsy within 30 days of scanning to obtain histopathological confirmation, the reference standard for diagnostic performance calculation.
Two independent experienced nuclear medicine physicians conduct blinded visual and semi-quantitative image analysis, measuring SUV values and tumor-to-background ratios for each tracer. Primary endpoints include comparative diagnostic sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the two PET agents for insulinoma localization. Secondary endpoints encompass human in vivo biodistribution, radiation dosimetry, and qualitative differences in tumor visualization and background interference.
All radiotracer administrations and PET/CT acquisitions adhere to standardized institutional operating procedures with radiation exposure within permissible diagnostic limits. Study staff monitor participants throughout imaging for adverse events related to intravenous injection or exendin-4-mediated effects, with standardized supportive protocols available for symptom management. Participants retain full voluntary withdrawal rights at any stage without impact on routine clinical care. All identifiable personal data are de-identified for analysis and long-term secure storage. Outcomes will be disseminated via peer-reviewed scientific publications to establish the clinical utility of PEG6-modified GLP-1R PET as an improved localization tool for insulinoma and guide surgical planning for hypoglycemic patients.
- Conditions
- Insulinoma
- Being tested
- [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT, [68Ga]Ga-HBED-CC-exendin-4 PET/CT
- Keywords
- insulinoma, GLP-1R, PET/CT, exendin-4
- Medical subject headings
- Insulinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CTDiagnostic test
Also called 68Ga-HBED-CC-PEG6-exendin-4
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.
[68Ga]Ga-HBED-CC-exendin-4 PET/CTDiagnostic test
Also called 68Ga-HBED-CC-exendin-4
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT; Diagnostic Test: [68Ga]Ga-HBED-CC-exendin-4 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measure lesion SUV, tumor-to-background ratio (TBR) on PET/CT images of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and reference tracer to compare image contrast and background interference.
Measured: Within 2 months after completion of two PET/CT scans and pathological confirmation
Comparison of renal uptake of the two GLP-1R radiotracers
Measure renal semi-quantitative uptake on PET/CT images of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and reference tracer to compare image contrast and background interference.
Measured: Within 2 months after completion of two PET/CT scans and pathological confirmation
Area under plasma radioactivity concentration-time curve (AUC0-t)
Dynamic PET data from the first 3 participants are used to calculate in vivo biodistribution parameters and organ radiation absorbed dose of the PEG6-modified investigational tracer.
Measured: Within 2 months after dynamic PET acquisition of the first three subjects
Internal radiation dosimetry of [68Ga]Ga-HBED-CC-PEG6-exendin-4
Dynamic PET data from the first 3 participants are used to calculate in vivo biodistribution parameters and organ radiation absorbed dose of the PEG6-modified investigational tracer.
Measured: Within 2 months after dynamic PET acquisition of the first three subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsulinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808879
- Sponsor's protocol ID
- 68Ga-HBED-CC-PEG6-exendin-4
- Other IDs
- 2025-PUMCH-D-003
- Acronym
- HBED-CC-PEG6-E
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. This study involves sensitive clinical imaging data, laboratory test results and personal medical information of patients, which is protected by institutional privacy management regulations and relevant medical data confidentiality requirements. In addition, the investigational radiotracer is still under exploratory clinical evaluation, and complete raw IPD contains unvalidated proprietary research data not suitable for external open dissemination. Study-related aggregate summary results will be published in peer-reviewed academic journals upon trial completion to realize public scientific disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-HBED-CC-PEG6-Exendin-4 PET/CT Imaging in the Diagnosis of Insulinoma
- ClinicalTrials.gov ID
- NCT07808879
- Acronym / sponsor ID
- HBED-CC-PEG6-E / 68Ga-HBED-CC-PEG6-exendin-4
- Conditions
- Insulinoma
- Keywords
- insulinoma, GLP-1R, PET/CT, exendin-4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adults. Most lesions are benign but typically small (1-2 cm), leading to poor detection sensitivity for conventional cross-sectional imaging including abdominal ultrasound and routine CT, which frequently fails to pinpoint tiny tumor foci. Incomplete resection results in persistent hypoglycemic symptoms and poor quality of life, creating an urgent clinical demand for sensitive, noninvasive localization modalities.
Glucagon-like peptide-1 receptor (GLP-1R) is abundantly overexpressed on benign insulinoma cells at levels approximately five times higher than normal pancreatic beta cells, making it an ideal molecular target for positron emission tomography. Earlier GLP-1R-targeted radiotracers such as [68Ga]Ga-NOTA-exendin-4 require high-temperature heating and post-labeling purification, limiting routine clinical deployment. The precursor probe [68Ga]Ga-HBED-CC-exendin-4 can be synthesized under mild conditions without purification but still presents relatively high physiological renal uptake that may obscure lesions adjacent to the kidney.
To further optimize pharmacokinetic behavior, a PEG6 linker was conjugated to the HBED-CC-exendin-4 scaffold to generate the novel radiotracer [68Ga]Ga-HBED-CC-PEG6-exendin-4. Preclinical mouse biodistribution and microPET experiments demonstrated significantly higher pancreatic and insulinoma tumor uptake, longer intralesional tracer retention, and an improved pancreas-to-kidney ratio relative to the non-PEGylated counterpart, which is expected to enhance lesion conspicuity on clinical PET/CT. Competitive blocking assays verified that tumor signal originates from specific GLP-1R binding. This novel radiopharmaceutical meets compendial standards for sterility and bacterial endotoxin and maintains high radiochemical purity for two physical half-lives after formulation.
This single-center prospective comparative trial will recruit 20 subjects aged 18-70 years with suspected or pathologically verifiable insulinoma. Eligible participants complete two radiotracer PET/CT examinations within a 7-day window at no personal cost: one using the PEG6-modified investigational agent and one using the original [68Ga]Ga-HBED-CC-exendin-4 reference tracer. The initial three enrolled subjects additionally undergo dynamic PET acquisition to generate human pharmacokinetic parameters and internal radiation dosimetry estimates. Baseline laboratory tests, clinical history, and prior imaging data are collected before radiotracer injection. All participants receive surgical resection or biopsy within 30 days of scanning to obtain histopathological confirmation, the reference standard for diagnostic performance calculation.
Two independent experienced nuclear medicine physicians conduct blinded visual and semi-quantitative image analysis, measuring SUV values and tumor-to-background ratios for each tracer. Primary endpoints include comparative diagnostic sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the two PET agents for insulinoma localization. Secondary endpoints encompass human in vivo biodistribution, radiation dosimetry, and qualitative differences in tumor visualization and background interference.
All radiotracer administrations and PET/CT acquisitions adhere to standardized institutional operating procedures with radiation exposure within permissible diagnostic limits. Study staff monitor participants throughout imaging for adverse events related to intravenous injection or exendin-4-mediated effects, with standardized supportive protocols available for symptom management. Participants retain full voluntary withdrawal rights at any stage without impact on routine clinical care. All identifiable personal data are de-identified for analysis and long-term secure storage. Outcomes will be disseminated via peer-reviewed scientific publications to establish the clinical utility of PEG6-modified GLP-1R PET as an improved localization tool for insulinoma and guide surgical planning for hypoglycemic patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Dual PET/CT Imaging with [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 | Experimental | Diagnostic Test: [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT, Diagnostic Test: [68Ga]Ga-HBED-CC-exendin-4 PET/CTAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CTAlso: 68Ga-HBED-CC-PEG6-exendin-4Investigational 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. | Diagnostic test | 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/CTAlso: 68Ga-HBED-CC-exendin-4Reference 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. | Diagnostic test | Single Arm: Dual PET/CT Imaging with [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 |
Primary outcome
Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization
Time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results
sensitivity of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 PET/CT.
Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization
Time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results
specificity of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 PET/CT.
Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization
Time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results
accuracy of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 PET/CT.
Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization
Time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results
PPV of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 PET/CT.
Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization
Time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results
NPV of [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 PET/CT.
4 secondary outcomes
Comparison of tumor-to-background ratios of the two GLP-1R radiotracers
Time frame: Within 2 months after completion of two PET/CT scans and pathological confirmation
Comparison of renal uptake of the two GLP-1R radiotracers
Time frame: Within 2 months after completion of two PET/CT scans and pathological confirmation
Area under plasma radioactivity concentration-time curve (AUC0-t)
Time frame: Within 2 months after dynamic PET acquisition of the first three subjects
Internal radiation dosimetry of [68Ga]Ga-HBED-CC-PEG6-exendin-4
Time frame: Within 2 months after dynamic PET acquisition of the first three subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. This study involves sensitive clinical imaging data, laboratory test results and personal medical information of patients, which is protected by institutional privacy management regulations and relevant medical data confidentiality requirements. In addition, the investigational radiotracer is still under exploratory clinical evaluation, and complete raw IPD contains unvalidated proprietary research data not suitable for external open dissemination. Study-related aggregate summary results will be published in peer-reviewed academic journals upon trial completion to realize public scientific disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-HBED-CC-PEG6-exendin-4 PET/CT and [68Ga]Ga-HBED-CC-exendin-4 PET/CT in people with Insulinoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaping Luo, MD (86-10-69154717, luoyaping@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization (time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.