Back to resultsThe Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Primary Purpose
Insulinoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-exendin-4
Sponsored by
About this trial
This is an interventional diagnostic trial for Insulinoma
Eligibility Criteria
Inclusion Criteria:
- 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent
Exclusion Criteria:
- 1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy
Sites / Locations
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients will undergo 68Ga-NOTA-exendin-4 PET/CT imaging
Arm Description
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. PET/CT imaging will be performed at 30-60 min post-injection.Visual and semiquantitative method will be used to assess the PET/CT images.
Outcomes
Primary Outcome Measures
Standard uptake value (SUV)
Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE Standard uptake value (SUV) of the lesion will be recorded
Secondary Outcome Measures
Full Information
NCT ID
NCT04979611
First Posted
July 27, 2021
Last Updated
September 15, 2023
Sponsor
First Affiliated Hospital of Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04979611
Brief Title
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Official Title
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The small insulinoma can not be detected by the CT or MRI. We use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. And the diagnostic value will be performed. A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed Description
The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated. And the comparation between PET diagnostic value and CT / MRI will be done.
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
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients will undergo 68Ga-NOTA-exendin-4 PET/CT imaging
Arm Type
Other
Arm Description
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. PET/CT imaging will be performed at 30-60 min post-injection.Visual and semiquantitative method will be used to assess the PET/CT images.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-exendin-4
Intervention Description
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously
Primary Outcome Measure Information:
Title
Standard uptake value (SUV)
Description
Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE Standard uptake value (SUV) of the lesion will be recorded
Time Frame
From right after tracer injection to 1-hours post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent
Exclusion Criteria:
1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weibing miao, MD
Phone
86-0591-87981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
shaobo yao, MD
Phone
86-0591-87981618
Email
yaoshaobo008@163.com
Facility Information:
Facility Name
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weibing Miao, MD
Phone
059187981618
Email
miaoweibing@126.com
First Name & Middle Initial & Last Name & Degree
Shaobo Yao, MD
Phone
059187981619
Email
yaoshaobo008@163.com
12. IPD Sharing Statement
Learn more about this trial
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
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