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| ID | Type | Description | Link |
|---|---|---|---|
| ZIAEB000073 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NOTA-exendin-4 PET/CT | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-exendin-4 | Drug | 68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans |
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| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events collection | Adverse events within 1 week after the injection and scanning of patients will be followed and assessed | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Li, MD | Contact | +86 10 69155502 | lifang@pumch.cn | |
| Yaping Luo, MD | Contact | +86 10 69155502 | luoyaping@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Li, MD | Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D007340 | Insulinoma |
| D046768 | Nesidioblastosis |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000612060 | 68Ga-NOTA-exendin-4 |
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| 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 |
| D044903 | Congenital Hyperinsulinism |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007003 | Hypoglycemia |