Comparing two methods for diagnosing a specific type of adrenal disorder

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

This study is testing whether a new imaging method can diagnose adrenal disorders better than a traditional sampling method in patients with adrenal nodules.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chongqing Medical University (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06833437 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with confirmed primary aldosteronism concurrent with autonomous cortisol secretion and adrenal nodules.

Not a fit: Patients who have contraindications for surgery, a history of adrenalectomy, or other specific adrenal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and less invasive diagnostic method for patients with specific adrenal disorders.

How similar studies have performed: While there have been studies on adrenal vein sampling, the use of 68Ga-Pentixafor PET/CT for this specific diagnosis is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Chongqing, Chongqing Municipality

• The First Affilated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Qifu Li

Conditions: Primary Aldosteronism, Autonomous Cortisol Secretion, Primary aldosteronism, Autonomous cortisol secretion, Adrenal venous sampling, 68Ga-Pentixafor PET/CT, outcome, multicenter randomized crossover trial