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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT | Experimental | The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-MAL-Cys39-exendin-4 | Drug | After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value | Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| GLP-1 receptor expression by histology compared to tracer uptake | Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT | 1 year |
| Incidence of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wang, Ph.D | Contact | +8602552271491 | fengwangcn@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Wang, Ph.D | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
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| ID | Term |
|---|---|
| D007340 | Insulinoma |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
| Adverse events within 1 week after the injection and scanning of patients will be followed and assessed |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |