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

Primary Purpose

Insulinoma

Status
Active
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
[68Ga]Ga-HBED-CC-exendin-4
[68Ga]Ga-NOTA-exendin-4
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Insulinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diagnostic value
Sensitivity and Specificity of [68Ga]Ga-HBED-CC-exendin-4 for insulinoma in comparison with [68Ga]Ga-NOTA-exendin-4 PET/CT.

Full Information

First Posted
September 2, 2021
Last Updated
October 13, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05034783
Brief Title
[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 13, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
[68Ga]Ga-HBED-CC-exendin-4
Other Intervention Name(s)
[68Ga]Ga-HBED-CC-exendin-4 injection
Intervention Description
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
Intervention Name(s)
[68Ga]Ga-NOTA-exendin-4
Other Intervention Name(s)
[68Ga]Ga-NOTA-exendin-4 injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic parameters
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of [68Ga]Ga-HBED-CC-exendin-4 for insulinoma in comparison with [68Ga]Ga-NOTA-exendin-4 PET/CT.
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
GLP-1R expression and SUV
Description
Correlation between GLP-1R expression and SUV in PET
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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