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

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De qué trata este estudio

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Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - 70 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 178 Estimado

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Acerca de la investigación

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.

Leer la descripción completa

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 prospectively enrolled. They were randomized to undergo 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in a crossover design for subtype diagnosis. The treatment strategy was determined based on the diagnostic results, with the primary endpoint being the biochemical complete remission rate at 6 months postoperatively. The study aims to compare the value of these two methods in the subtype diagnosis of PA.

¿Quién podría participar?

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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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento doble

68Ga-Pentixafor PET/CT group

Patients in the 68Ga-Pentixafor PET/CTgroup will first undergo 68Ga-Pentixafor PET/CT, followed by adrenal venous sampling (AVS). The subsequent treatment will be guided based on the diagnostic results.

Diagnostic Test: 68Ga-Pentixafor PET/CT

AVS group

Patients in the adrenal venous sampling (AVS) will first undergo adrenal venous sampling (AVS) , followed by 68Ga-Pentixafor PET/CT. The subsequent treatment will be guided based on the diagnostic results.

Diagnostic Test: AVS

68Ga-Pentixafor PET/CT DIAGNOSTIC_TEST

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

AVS DIAGNOSTIC_TEST

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

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