RecruitingNot ApplicableNCT06238232

Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling to Determine Treatment in Primary Aldosteronism: A Multicenter Randomized Clinical Trial


Sponsor

Qifu Li

Enrollment

320 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • (1)Getting the written informed consent (2)ARR ≥20 (pg/ml)/ (μIU/ml) or ARR ≥ 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT).

Exclusion Criteria9

  • Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l.
  • 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 or with adrenocortical insufficiency.
  • 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

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Interventions

DIAGNOSTIC_TEST68Ga-Pentixafor PET/CT

The patients had a normal diet with no special preparation before 68Ga-Pentixafor PET/CT imaging. The dosage of intravenously injected 68Ga-Pentixafor was calculated based on the patient's weight (1.85 MBq \[0.05mCi\]/kg). Local PET/CT scanning of the upper abdomen was performed on a hybrid PET/CT scanner at 10 minutes after the injection of the intravenous tracer, respectively.


Locations(1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT06238232


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