NCT04185350

Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor. The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.

Detailed description

Since GLP-1R is expressed in human β-cells and highly overexpressed in insulinomas，multiple GLP-1R-targeted radiopharmaceuticals were devoted to insulinoma localization imaging.68Ga-NOTA-MAL-Cys39-exendin-4 is an optimal probe targeting GLP-1R. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-MAL-Cys39-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.The investigators will determine the use of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging.

Conditions

• Insulinoma

Interventions

Type	Name	Description
DRUG	68Ga-NOTA-MAL-Cys39-exendin-4	After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.

Timeline

• Start date: 2019-05-05
• Primary completion: 2020-04-05
• Completion: 2020-05-05
• First posted: 2019-12-04
• Last updated: 2019-12-04

Locations

1 site across 1 country: China