68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

Study Overview
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Brief Summary
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This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 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
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68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The investigators will determine the use of 68Ga-NOTA-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging. GLP-1R imaging, specifically expressed on pancreatic beta cell surface, might help with diagnosis of different types of nesidioblastosis (ie. focal or diffuse type), and may improve the treatment strategy of nesidioblastosis. The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.

Official Title
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68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

Conditions
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Insulinoma, Nesidioblastosis

Intervention / Treatment
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* Drug: 68Ga-NOTA-exendin-4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration <3.0 mM, insulin >3 µU/ml, and C-peptide >0.6 ng/ml). Conventional imaging within 1 month Signed written consent Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study) Exclusion Criteria: Pregnancy Breastfeeding Renal function: serum creatinine > 3.0 mg/dl Known allergy against exendin-4 Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NOTA-exendin-4 PET/CT<br>The patients were injected with 55.5-111 MBq of 68Ga-NOTA-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 30-60 min later. | Drug: 68Ga-NOTA-exendin-4<br>* 68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans<br>* Other names: 68Ga-NOTA-MAL-cys40-exendin-4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 1 week after the injection and scanning of patients will be followed and assessed | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, glucagon-like peptide-1 receptor (GLP-1R) imaging