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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Peking Union Medical College Hospital

Current Primary Outcome: Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse events collection [ Time Frame: 1 week ]

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


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: September 24, 2015
Date Started: February 2014
Date Completion: December 2016
Last Updated: September 24, 2015
Last Verified: May 2015