Comparing two methods for diagnosing a specific type of adrenal disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to validate the accuracy of 68Ga-Pentixafor PET/CT compared to adrenal venous sampling (AVS) in diagnosing patients with primary aldosteronism (PA) and autonomous cortisol secretion (ACS) who have adrenal nodules. It is a prospective, multicenter, randomized crossover trial where enrolled patients will undergo both diagnostic methods to determine which is more effective. The primary endpoint is the biochemical complete remission rate at six months post-surgery, allowing for a comparison of the two diagnostic approaches in terms of clinical outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affilated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Qifu Li
• Email: liqifu@yeah.net
• Phone: +86 023-89011552

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.