RecruitingNCT06635993

Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion


Sponsor

Qifu Li

Enrollment

97 participants

Start Date

Aug 12, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

To evaluate the accuracy of 68Ga-Pentixafor PET-CT in the classification diagnosis of primary aldosteronism concurrent with autonomous cortisol secretion patient, using AVS and/or postoperative remission as the reference standard for classification diagnosis.


Eligibility

Inclusion Criteria5

  • Getting the written informed consent
  • The clear diagnosis of primary aldosteronism;
  • Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l;
  • Patients who are willing to undergo surgery;
  • Adrenal CT or MRI scan of the adrenal glands with nodule (≥1cm).

Exclusion Criteria10

  • 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;
  • Patients who are allergic to contrast media and cannot tolerate AVS;
  • 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); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
  • Consider patients with bilateral cortisol hypersecretion such as PBMAH or PPNAD.

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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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NCT06635993