NCT06759740撤回不适用
An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiation dose to major organs and tumors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
- •Age ≥ 18 years.
- •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).
- •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).
- •Negative for sulfonylurea drugs and insulin autoantibodies.
- •ECOG performance status ≤ 2, able to tolerate the examination.
- •All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.
排除标准
- •History of allergy or hypersensitivity to the components or excipients of the investigational drug.
- •Claustrophobia or inability to tolerate imaging procedures for other reasons.
- •Clinically significant active infection as determined by the investigator.
- •History or current presence of uncontrolled primary or metastatic brain tumors.
- •Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:
- •Poorly controlled diabetes.
- •Congestive heart failure.
- •Myocardial infarction within the past 12 months.
- •Uncontrolled and unstable hypertension.
- •Chronic kidney disease or liver disease.
- •Severe pulmonary diseases.
- •Poor compliance and inability to complete study procedures as expected.
- •Any other conditions that the investigator considers unsuitable for participation in the clinical study.
结局指标
主要结局
Radiation dose to major organs and tumors
时间窗: 7 days
次要结局
未报告次要终点
研究者
Xie Yang
Director
The Affiliated Hospital Of Southwest Medical University
研究点 (1)
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