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NCT04979611 Clinical Trial

The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma

Insulinoma Clinical Trial

Official title:
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04979611
Other study ID # FirstAHFujian11
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2025

Study information
Verified date September 2023
Source First Affiliated Hospital of Fujian Medical University
Contact weibing miao, MD
Phone 86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Ga-NOTA-exendin-4
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously

Locations
Country Name City State
China Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 From right after tracer injection to 1-hours post-injection
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