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PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism

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.

ClinicalTrials.gov IDNCT07027254

PhaseNA

Enrollment90

SponsorSeoul National University Hospital

Age19 Years

SexALL

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Conditions studied

Primary Aldosteronism, Secondary Hypertension, Aldosterone-Producing Adenoma, Idiopathic Hyperaldosteronism, Adrenalectomy

About this study

Interventions

Diagnostic Test: 68Ga-pentixafor PET/CT — Diagnostic 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).

Primary outcomes

Biochemical remission rate after adrenalectomy (surgery group only) (6 months after adrenalectomy)

Eligibility information

Inclusion Criteria: * Age ≥19 years * Diagnosed with PA per 2016 Endocrine Society guidelines * Underwent adrenal CT * Signed informed consent Exclusion Criteria: * 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 * Individuals with a history of abdominal open surgery or retroperitoneal surgery on the same side as the planned adrenalectomy * Any individual deemed unsuitable for the study at the discretion of the investigator

Study locations

Samsung Medical Center, Seoul, Gangnam-gu 06351 South Korea
Seoul National University Hospital, Seoul, Jongno-gu 03080 South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.