RecruitingNot ApplicableNCT06833437

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

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


Sponsor

Qifu Li

Enrollment

178 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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, and to determine whether the diagnostic accuracy of 68Ga-Pentixafor PET/CT is non-inferior to AVS.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Getting the written informed consent;
  • PA conccurent with autonomous cortisol secretion;
  • Patients with hypertension aged 18-70 years;

Exclusion Criteria13

  • 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.

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Interventions

DIAGNOSTIC_TEST68Ga-Pentixafor PET/CT

Patients in the 68Ga-Pentixafor PET/CT group will first undergo 68Ga-Pentixafor PET/CT, followed by adrenal venous sampling (AVS). The subsequent treatment will be guided based on the diagnostic results. The diagnosis of unilateral PA was made if LISUVmax ≥1.50 or or unilateral functional adrenal tumor based on 68Ga-Pentixafor PET/CT

DIAGNOSTIC_TESTAVS

Patients in the adrenal venous sampling (AVS) group will first undergo adrenal venous sampling (AVS), followed by 68Ga-Pentixafor PET/CT. The subsequent treatment will be guided based on the diagnostic results. The diagnosis of unilateral PA was made LI ≥ 4 or LI 2-4 with contralateral suppression or typical nodule on the dominant side by CT


Locations(1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT06833437


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