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

Insulinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02560376
• Other study ID #: PUMCHNM12
• Secondary ID: ZIAEB000073
• Status: Recruiting
• Phase: Phase 0
• First received: September 24, 2015
• Last updated: September 24, 2015
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Peking Union Medical College Hospital
• Contact: Fang Li, MD
• Phone: +86 10 69155502
• Email: lifang[@]pumch.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Insulinoma
• Nesidioblastosis

Intervention

Drug:
• 68Ga-NOTA-exendin-4
68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis		1 year	No
Secondary	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients will be followed and assessed	1 week	Yes