Clinical Study of Chemokine Receptor 4 (CXCR4)-Mediated Precision Targeting of 18F for the Diagnosis of Aldosteronism in Primary Aldosteronism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- target background ratio(TBR)
研究概览
简要总结
The study was proposed to include 20 patients with clinical suspicion of primary aldosteronism for [18F]AlF-NOTA-pentixather PET/CT imaging and to analyze the specificity and sensitivity of [18F]AlF-NOTA-pentixather PET/CT for the diagnosis of APA by comparison with the final pathological findings.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persistent hypertension or refractory hypertension (blood pressure >140/90 mmHg with a combination of three antihypertensive drugs, including diuretics) with hypokalemia of blood pressure >160/100 mmHg.
- •Uncontrollable hypokalemia with or without hypertension. Persistent hypertension or refractory hypertension with blood pressure >160/100 mmHg and aldosterone-renin ratio (ARR) ≥30 (ng/dl)/(ng/ml/h).
- •Positive captopril test (≤30% decrease in plasma aldosterone level after captopril administration) is a sufficient but not mandatory condition.
- •Patients with CT showing unilateral or bilateral adrenal nodules with well-defined borders but normal serum potassium and ARR <30 (ng/dl)/(ng/ml/h) were also included in the study.
排除标准
- •Female patients who are pregnant (or intend to become pregnant within six months), breastfeeding, or unwilling to use contraception.
- •Abnormal cardiopulmonary function or mental status, unable to tolerate prone for 20 minutes.
- •Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved study protocol.
- •Other conditions deemed by the investigator to be inappropriate for participation in this study.
研究组 & 干预措施
[18F]AlF-NOTA-pentixather
No special preparation such as fasting and fasting is required before the examination. The radiotracer 18F-AlF-NOTA-pentiaxther PET/CT (dose 4.81 MBq/Kg body weight) was injected intravenously according to the patient's body weight, and the drug was synthesized by the Department of Nuclear Medicine of Sichuan Provincial People's Hospital immediately before the examination. Before the examination, patients were instructed to urinate as many times as possible to reduce the possible influence of the residual radiotracer in the renal pelvis and calyces on the image quality. The whole-body PET/CT examination from the top of the skull to the root of the thigh was performed using a PET/CT examination instrument (Siemens Biograph mCT Flow) 50-60 minutes after the injection of radiopharmaceuticals. Flow Motion flow scanning technology with a matrix of 128x128 and a layer thickness of 3 mm was used. all PET images were reconstructed iteratively.
干预措施: [18F]AlF-NOTA-pentixather PET/CT (Diagnostic Test)
结局指标
主要结局
target background ratio(TBR)
时间窗: Within a week of completion of imaging
The ratio of SUVmax of adrenal lesions to SUVmean of the liver background and the ratio of SUVmax of adrenal lesions to SUVmean of the contralateral adrenal gland were analyzed in the study as the target background ratio(TBR).
Maximum standardized uptake value(SUVmax)
时间窗: Within a week of completion of imaging
Maximum standardized uptake value of suspicious adrenal lesion on \[18F\]AlF-NOTA-pentixather PET/CT
次要结局
未报告次要终点
研究者
Hao Wang
Associate senior physician
Sichuan Provincial People's Hospital