Hypoglycaemia
Conditions
Brief summary
Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.
Interventions
RADIATION68Ga-DOTA-SEMA
68Ga-DOTA-SEMA is GLP1R imaging agent
Sponsors
The Affiliated Hospital Of Southwest Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF). 2. Age ≥ 18 years. 3. Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.73 m²). 4. Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause). 5. Negative for sulfonylurea drugs and insulin autoantibodies. 6. ECOG performance status ≤ 2, able to tolerate the examination. 7. All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.
Exclusion criteria
1. History of allergy or hypersensitivity to the components or excipients of the investigational drug. 2. Claustrophobia or inability to tolerate imaging procedures for other reasons. 3. Clinically significant active infection as determined by the investigator. 4. History or current presence of uncontrolled primary or metastatic brain tumors. 5. Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to: 1. Poorly controlled diabetes. 2. Congestive heart failure. 3. Myocardial infarction within the past 12 months. 4. Uncontrolled and unstable hypertension. 5. Chronic kidney disease or liver disease. 6. Severe pulmonary diseases. 6. Poor compliance and inability to complete study procedures as expected. 7. Any other conditions that the investigator considers unsuitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation dose to major organs and tumors | 7 days |
Countries
China
Outcome results
None listed