A Randomized Controlled Trial to Evaluate the Effect of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Patients With Primary Aldosteronism (The PETAL Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Biochemical remission rate after adrenalectomy (surgery group only)
研究概览
简要总结
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.
详细描述
Primary aldosteronism (PA) is a common cause of secondary hypertension. Accurate subtype classification (unilateral vs. bilateral) is essential to determine whether patients should receive adrenalectomy or medical therapy. AVS is the current gold standard but has limitations, including its invasiveness, technical difficulty, and risk of failure. Recently, non-invasive imaging techniques such as 68Ga-pentixafor PET/CT and 11C-metomidate PET/CT have emerged as promising alternatives for subtype classification. These PET-based methods target molecular markers (e.g., CXCR4, CYP11B2) and show moderate to high concordance rates with AVS (66.7%-90% for pentixafor). However, there is insufficient prospective evidence on whether these modalities can improve treatment outcomes. This randomized controlled trial aims to assess whether adding 68Ga-pentixafor PET/CT to standard AVS improves surgical outcomes in patients with unilateral PA. Participants are randomized 1:1 to undergo either AVS alone or AVS plus 68Ga-pentixafor PET/CT. Additionally, 11C-metomidate PET/CT is performed in the intervention arm purely for research purposes and will not influence treatment decisions. By improving the precision of subtype classification, this study aims to improve patient selection for adrenalectomy, and ultimately enhance clinical outcomes in primary aldosteronism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The nuclear medicine physician interpreting PET/CT scans is masked to AVS results. However, participants and treating clinicians are not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years
- •Diagnosed with PA per 2016 Endocrine Society guidelines
- •Underwent adrenal CT
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Biochemical remission rate after adrenalectomy (surgery group only)
时间窗: 6 months after adrenalectomy
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.
次要结局
- Clinical remission rate after adrenalectomy or initiation of medical therapy(6 months after treatment (surgery or medication))
- Agreement rate between PET/CT imaging and adrenal venous sampling (AVS)(6 months after treatment (surgery or medication))
- Concordance between AVS-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2(6 months after treatment)
- Concordance between PET/CT-based lateralization and immunohistochemical (IHC) expression of CXCR4 and CYP11B2(6 months after treatment)
- Correlation between the AVS-derived lateralization index and the SUVmax ratio on PET/CT(6 months after treatment)
- Change in plasma aldosterone concentration/aldosterone-to-renin ratio (ARR)(Baseline and 6 months after treatment)
- Rate of blood pressure normalization(6 months after treatment)
- Change in antihypertensive medication use(Baseline and 6 months after treatment)
- Change in serum potassium level(Baseline and 6 months after treatment)
- Frequency and percentage of histologic subtype classification in resected adrenal tissue(3 months after adrenalectomy)
- Size of resected adrenal tumors(3 months after adrenalectomy)
- Correlation between somatic mutations and PET/CT SUVmax ratio(3 months after adrenalecotmy)
研究者
Su-jin Kim
Professor, Department of Surgery, Seoul National University Hospital
Seoul National University Hospital