NCT07119242进行中（未招募）3 期
Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- The sensitivity and specificity at the subject level
研究概览
简要总结
Evaluate the diagnostic efficacy, pharmacokinetics and safety of 68Ga-DOTATATE injection PET/CT in NETs
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
- •Age > 18 years old, no gender limit;
- •Karnofsky status score >50 points;
- •Expected survival time >3 months;
- •Those who have a history of neuroendocrine tumors,but require PET/CT examination for structure, location and function evaluation and disease management, and have measurable lesions; CT, MRI, 18F-FDG PET/CT or other imaging examinations are suspected of being NETs or those with space-occupying lesions and at least one of the following:
- •① Biochemical and tumor biomarkers results of blood or urine suggest that the subject is suspected of suffering from NETs (chromogranin A,neurospecific enolase,vasoactive intestinal peptide, serotonin (urinary 5-HIAA), gastrin, somatostatin,catecholamines,calcitonin,fasting insulin,C-Peptides(proinsulin) orglucagon abnormal biochemical indicators related to neuroen docrine tumors);
- •②Multiple endocrine neoplasia type 1 (MEN1) and Lindau syndrome (VHL) with familial tendency to be susceptible to NETs (symptomatic and/or asymptomatic cases; with biochemical or anatomical imaging evidence of the disease);
- •The subjects or their guardians fully understand the content,process and possible risks of the trial and voluntarily sign the informed consent form.
排除标准
- •Known to be allergic to any components or excipients of 68Ga-DOTATATE injection;
- •Unable to remain relatively still during the imaging examination (such as coughing, severe arthritis, etc.), or body shape and/or weight exceeds the applicable range of the examination equipment;
- •Unable to complete the imaging examination specified in the plan due to claustrophobia,radiation phobia or personal wishes;
- •With a history of concurrent active infection or severe heart disease;
- •Those who have used long-acting somatostatin analogs within 28 days or short-acting somatostatin analogs within 2 days before the scheduled PET/CT examination of 68Ga-DOTATATE injection;
- •Those who receive long-term and repeated treatment with high-dose glucocorticoids;
- •Pregnant or lactating women,or those who do not agree to take effective contraceptive measures from the date of signing the informed consent form to 3 months after administration;
- •Blood test results
- •a) WBC: < 2 x 109/L, b) Haemoglobin:< 8.0 g/dL, c) Platelets: s 50 x 109/L, d) ALT. AST. AP:> 5 times ULN, e) Bilirubin:> 3 times ULN, f) Serum creatinine:> 1.5 times ULN
- •Those who have participated in other interventional clinical trials or are participating in other interventional clinical trials within 1 month or 5 drug half-lives( whichever is longer ) before the date of signing the informed consent,or have participated in clinical trials of radioactive drugs within 1 year before the date of signing the informed consent, and the withdrawal time is less than 3 months until the date of signing the informed consent;
- •Investigators considered unsuitable to participate in this trial.
研究组 & 干预措施
68Ga-DOTATATE Injection
Experimental
干预措施: 68Ga-DOTATATE Injection (Drug)
结局指标
主要结局
The sensitivity and specificity at the subject level
时间窗: Within 28 days following 68Ga-DOTATATE injection PET/CT in NETs
The sensitivity and specificity at the subject level Sensitivity = Number of true positive/(Number of true positive + Number of false negative) Specificity = Number of true negative/(Number of true negative + Number of false positive)
次要结局
未报告次要终点
研究者
研究点 (1)
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