💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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. Exclusion criteria
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.
💊
What it tests
- 68Ga-Pentixafor PET/CT
- AVS
The First Affilated Hospital of Chongqing Medical University
Chongqing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.