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

October 13, 2022 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [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.
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.
Other Names:
  • [68Ga]Ga-HBED-CC-exendin-4 injection
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.
Other Names:
  • [68Ga]Ga-NOTA-exendin-4 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic parameters
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: 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.
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
GLP-1R expression and SUV
Time Frame: through study completion, an average of 1 year
Correlation between GLP-1R expression and SUV in PET
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

October 13, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-NM-EX4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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