Status:

RECRUITING

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)

Lead Sponsor:

Qifu Li

Collaborating Sponsors:

The Affiliated Hospital Of Southwest Medical University

Changzhi Medical College

Conditions:

Primary Aldosteronism

Autonomous Cortisol Secretion

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

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,...

Detailed Description

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 prosp...

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.

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2029

Estimated Enrollment :

178 Patients enrolled

Trial Details

Trial ID

NCT06833437

Start Date

August 1 2024

End Date

December 31 2029

Last Update

February 5 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT) | DecenTrialz