68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT): a Randomized Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- The proportion of complete biochemical remission
研究概览
简要总结
To validate the accuracy of 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in subtype diagnosis of PA/ACS patients with adrenal nodules, based on biochemical and clinical remission outcomes, and to determine whether the diagnostic accuracy of 68Ga-Pentixafor PET/CT is non-inferior to AVS.
详细描述
This is a prospective, multicenter, randomized crossover trial. Patients with a confirmed diagnosis of primary aldosteronism (PA) or autonomous cortisol secretion (ACS) with adrenal nodules were prospectively enrolled. They were randomized to undergo 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in a crossover design for subtype diagnosis. The treatment strategy was determined based on the diagnostic results, with the primary endpoint being the biochemical complete remission rate at 6 months postoperatively. The study aims to compare the value of these two methods in the subtype diagnosis of PA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Getting the written informed consent;
- •PA conccurent with autonomous cortisol secretion;
- •Patients with hypertension aged 18-70 years;
- •CT or MRI scan of the adrenal glands with adenoma.
排除标准
- •Exclusion Criteria:
- •Unable to complete 68Ga-Pentixafor PET/CT or AVS;
- •Refusal of surgery or contraindications for surgery;
- •PA patients who meet the by-passing AVS criteria [i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone >300pg/ml]
- •Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history];
- •Suspicion of pheochromocytoma or adrenal carcinoma;
- •Patients with actively malignant tumor;
- •Patients who have adrenalectomy history;
- •Long-term use of glucocorticoids;
- •Pregnant or lactating women; with alcohol or drug abuse and mental disorders;
- •Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m²) or Underweight (BMI≤18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
- •Suspected PBMAH or PPNAD;
- •Poor compliance or any other reason deemed unsuitable for inclusion by the investigators;
- •Patients with adrenal insufficiency requiring hormone replacement therapy.
研究组 & 干预措施
68Ga-Pentixafor PET/CT group
Patients in the 68Ga-Pentixafor PET/CTgroup will first undergo 68Ga-Pentixafor PET/CT, followed by adrenal venous sampling (AVS). The subsequent treatment will be guided based on the diagnostic results.
干预措施: 68Ga-Pentixafor PET/CT (Diagnostic Test)
AVS group
Patients in the adrenal venous sampling (AVS) will first undergo adrenal venous sampling (AVS) , followed by 68Ga-Pentixafor PET/CT. The subsequent treatment will be guided based on the diagnostic results.
干预措施: AVS (Diagnostic Test)
结局指标
主要结局
The proportion of complete biochemical remission
时间窗: At 6 months of follow-up
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
次要结局
- The proportion of complete clinical remission(At 6 months of follow-up)
- In surgical population, the proportion of complete biochemical remission(At 6 months of follow-up)
- In surgical population, the proportion of complete clinical remission(At 6 months of follow-up)
- In surgical population, the accuracy in identifying unilateral primary aldosteronism.(At 6 months of follow-up)
- In the surgical treatment group, the remission rate of cortisol autonomous secretion(at the 6-month follow-up assessment)
研究者
Qifu Li
Primary investigator
Chongqing Medical University