Insulinoma
Conditions
Brief 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.
Interventions
DRUG68Ga-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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patient volunteers and signs an informed consent form. 2. age ≥18 and ≤75 years old; 3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad; 4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml); 5. Conventional imaging within 3 month.
Exclusion criteria
1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases; 2. Breast feeding; 3. Pregnancy or the wish to become pregnant within 6 months; 4. Renal function: serum creatinine \> 3.0 mg/dl; 5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value | 1 year | Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GLP-1 receptor expression by histology compared to tracer uptake | 1 year | Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT |
| Incidence of Adverse Events | Adverse events within 1 week after the injection and scanning of patients will be followed and assessed | This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting |
Countries
China
Contacts
Primary ContactFeng Wang, Ph.D
Outcome results
None listed