68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism

Study Overview
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Brief Summary
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To evaluate the value of 68Ga-Pentixafor PET/CT in the diagnosis of primary aldosteronism subtype

Detailed Description
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This is a prospective study. We will enroll 100 patients with definite diagnosis of PA using adrenal venous sampling(AVS) as the gold standard for subtype to evaluate the value of 68Ga-pentixaforPET/CT in the diagnosis of PA.

Official Title
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68Ga-Pentixafor PET/CT for the Subtyping Diagnosis of Primary Aldosteronism: A Prospective Diagnostic Accuracy Study

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Diagnostic Test: 68Ga-Pentixafor PET/CT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PA diagnosis confirmed by at least one confirmatory test willingness to undergo AVS and surgery informed consent to participate in the study. Exclusion Criteria: PA patients who met guideline criteria for bypassing AVS [i.e. younger than 35 years old, with typical APA characteristics (plasma aldosterone >300pg/ml, plasma renin < 2·5mIU/l, serum potassium <3·5mmol/l, CT indicated unilateral 1cm low-density adenoma); failed adrenal vein cannulation during AVS; Subtyping diagnosis was inconclusive based on AVS results (e.g. aldosterone/cortisol ratio in bilateral adrenal veins lower than the peripheral vein, or missing data); pregnant or lactating women; patients with a history of uncontrolled malignant tumor; concurrent Cushing's syndrome [including mild autonomous cortisol secretion: cortisol after 1mg dexamethasone suppression test (DST)>138 nmol/l or cortisol after 2mg DST >50 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)<10pg/ml; diagnosis of familial hyperaldosteronism; imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma; unsuitable for surgery, such as heart failure with New York Heart Association (NYHA) class III or IV, severe anemia (Hemoglobin<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate<30ml/min/m; alcohol or drug abuse and mental disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| unilateral primary aldosteronism(UPA)<br>PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI ≥ 4; If LI between 2 and 4, should be combined with contralateral inhibition index < 1 or CT indicate typical adenomas on the dominant side. | Diagnostic Test: 68Ga-Pentixafor PET/CT imaging<br>* 68Ga-Pentixafor PET/CT imaging<br>|
| bilateral adrenal hyperplasia(BAH)<br>PA confirmatory tests was positive; successful intubation (SI ≥ 3) and LI < 2; or LI between 2 and 4 but does not meet the UPA conditions | Diagnostic Test: 68Ga-Pentixafor PET/CT imaging<br>* 68Ga-Pentixafor PET/CT imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of 68Ga-PentixaforPET/CT in subtyping diagnosis of PA | AUC | at the end of study(the last enrolled patient completed a 3-month follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET CT; Primary aldosteronism; Adrenal venous sampling