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

Early Phase 1

• Conditions: Nesidioblastosis; Insulinoma
• Interventions: Drug: 68Ga-NOTA-exendin-4

• Registration Number: NCT02560376
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Status Verified: 2015-05
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-24
• Last Update Submitted: 2015-09-24
• Study First Posted: 2015-09-25
• Last Update Posted: 2015-09-25
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-exendin-4 PET/CT	68Ga-NOTA-exendin-4	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.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	1 week	Adverse events within 1 week after the injection and scanning of patients will be followed and assessed

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China