This study is a randomized controlled trial to assess the clinical utility of gallium-68 pentixafor PET/CT in the management of primary aldosteronism (PA). We aim to evaluate whether the addition of 68Ga-pentixafor PET/CT to standard adrenal venous sampling (AVS) improves surgical outcomes in patients with unilateral PA.
Age ≥19 years
Diagnosed with PA per 2016 Endocrine Society guidelines
Underwent adrenal CT
Signed informed consent
Women who are pregnant, breastfeeding, or may become pregnant
Individuals who refuse to undergo surgery
Individuals for whom 68Ga-Pentixafor PET/CT, 11C-Metomidate PET/CT, or adrenal venous sampling (AVS) is not feasible or is refused due to underlying conditions
Individuals who refuse or experience adverse effects from dexamethasone premedication required for 11C-Metomidate PET/CT
Parallel
68Ga-pentixafor PET/CT
Diagnostic testDiagnostic PET/CT imaging using gallium-68 labeled pentixafor to assess adrenal CXCR4 expression in patients with primary aldosteronism. The imaging is performed prior to treatment allocation and used to assist lateralization of aldosterone production when combined with adrenal venous sampling (AVS).
Biochemical remission rate after adrenalectomy (surgery group only)
Number of participants achieving biochemical success as defined by PASO criteria will be assessed. Biochemical success is defined as normalization or improvement in aldosterone-to-renin ratio (ARR) and correction of hypokalemia without potassium supplementation in patients with unilateral primary aldosteronism who underwent adrenalectomy.
Clinical remission rate after adrenalectomy or initiation of medical therapy
Number of participants achieving clinical success according to PASO (surgical group) or PAMO (medical group) criteria will be assessed. Clinical success includes normalization of blood pressure and reduction in number or dose of antihypertensive medications after surgery or medical therapy.
Agreement rate between PET/CT imaging and adrenal venous sampling (AVS)
Agreement rate between 68Ga-pentixafor PET/CT (+11C-metomidate PET/CT for subgroup) and adrenal venous sampling (AVS) will be assessed. Diagnostic agreement will be evaluated based on lateralization patterns from PET/CT and AVS using predefined laterality thresholds.
Concordance between AVS-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2
Concordance between AVS-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2 will be assessed. IHC positivity for CXCR4 and CYP11B2 will be recorded as presence or absence in each adrenal lesion. Concordance will be evaluated by comparing lateralization results from AVS with the presence or absence of expression.
Concordance between PET/CT-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2
Concordance between PET/CT-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2 will be assessed. IHC positivity for CXCR4 and CYP11B2 will be recorded as presence or absence in each adrenal lesion. Concordance will be evaluated by comparing PET/CT-based lateralization with the presence or absence of expression in the corresponding adrenal tissue.
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Seoul National University Hospital
Lead sponsor
Samsung Medical Center
Collaborator
