Molecular Imaging Versus Adrenal Vein Sampling for the Detection of Surgically Curable Primary Aldosteronism : A Prospective Within-Patient Trial.

IF 19.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

Annals of Internal Medicine Pub Date : 2025-03-01 Epub Date: 2025-03-04 DOI:10.7326/ANNALS-24-00761

Emily Goodchild, Xilin Wu, Russell Senanayake, James MacFarlane, Giulia Argentesi, Kate Laycock, Waiel A Bashari, Claudia P Cabrera, Samuel M O'Toole, Jackie Salsbury, Daniela Benu, Yun-Ni Lee, Aldons C N Chua, Matthew Matson, Brendan Koo, Laila Parvanta, Nicholas Hilliard, Vasilis Kosmoliaptsis, Alison Marker, Daniel M Berney, Kiera Drew, Wilson Tan, Roger Foo, Charles A Mein, Eva Wozniak, Jessica Kearney, Emanuel Savage, Anju Sahdev, Nicholas Bird, Graham Smith, Matthew Hird, Victoria Warnes, Daniel Gillett, Anne Dawnay, Elizabeth Adeyeye, Franklin Aigbirhio, Alasdair McIntosh, Alex McConnachie, J Kennedy Cruickshank, Heok Cheow, Mark Gurnell, William M Drake, Morris J Brown

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引用次数: 0

Abstract

Background: Primary aldosteronism (PA) causes hypertension and is potentially surgically curable when it is caused by a unilateral aldosterone-producing adrenal adenoma (APA). Adrenal vein sampling (AVS) is required to guide surgery, but it is invasive, is technically difficult, and has limited availability.

Objective: To determine whether the accuracy of post-dexamethasone [¹¹C]metomidate ([¹¹C]MTO) positron emission tomography-computed tomography, a diagnostic test for APAs, is superior or noninferior to the accuracy of AVS in predicting outcomes from unilateral adrenalectomy, and whether [¹¹C]MTO is interchangeable with its longer-half-life analogue, para-chloro-2-[¹⁸F]fluoroethyletomidate ([¹⁸F]CETO).

Design: Prospective within-patient comparison of diagnostic interventions. (ClinicalTrials.gov: NCT02945904).

Setting: Three referral centers.

Participants: 174 patients with PA desiring surgery if a unilateral source of PA was diagnosed.

Intervention: [¹¹C]MTO and AVS in 169 patients, plus [¹⁸F]CETO in the final 31.

Measurements: International consensus criteria for biochemical and clinical success at 6 and 24 months after surgery; κ statistic and Bland-Altman analyses comparing predictions of surgical outcomes by [¹¹C]MTO and [¹⁸F]CETO.

Results: Eighty-nine of 169 (52.7%), 78 of 169 (46.2%), and 43 of 169 (25.4%) patients were predicted to have unilateral PA by [¹¹C]MTO, AVS, or both, respectively. One hundred of 169 (59.1%) were assigned to adrenalectomy by the multidisciplinary team; primary outcome data were available for 156 of 169. Predictions were most accurate for complete or partial biochemical success ([¹¹C]MTO, 71.3% [95% CI, 61.0% to 80.1%]; AVS, 62.8% [CI, 52.2% to 72.6%]) and least accurate for complete clinical success (home blood pressure <135/85 mm Hg off treatment). The 95% CIs around differences between accuracies crossed zero, excluding superiority for [¹¹C]MTO, but not the prespecified lower bound of -17%, allowing [¹¹C]MTO to be declared noninferior to AVS. [¹⁸F]CETO and [¹¹C]MTO agreed in 29 of 31 patients (κ = 0.85 [CI, 0.68 to 1.00]).

Limitation: The accuracy of [¹¹C]MTO could be assessed only in the surgical group.

Conclusion: Molecular imaging is an accurate, noninvasive alternative to AVS.

Primary funding source: National Institute for Health and Care Research.

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分子成像与肾上腺静脉取样检测手术可治愈的原发性醛固酮增多症：一项前瞻性患者试验。

背景：原发性醛固酮增多症（PA）引起高血压，当它是由单侧醛固酮分泌肾上腺腺瘤（APA）引起时，有可能通过手术治愈。肾上腺静脉采样（AVS）需要指导手术，但它是侵入性的，技术上困难，并且可用性有限。目的：确定地塞米松后[11C]美托咪酯（[11C]MTO）正电子发射断层扫描-计算机断层扫描（APAs的诊断试验）在预测单侧肾上腺切除术预后方面的准确性是否优于或不低于AVS的准确性，以及[11C]MTO是否可与其半衰期较长的类似物对氯-2-[18F]氟乙基咪酯（[18F]CETO）互换。设计：诊断干预措施的前瞻性患者内比较。(ClinicalTrials.gov: NCT02945904)。环境：三个转诊中心。参与者：174例被诊断为单侧PA源的PA患者希望手术。干预：[11C]MTO和AVS 169例，[18F]CETO 31例。测量：术后6个月和24个月生化和临床成功的国际共识标准；κ统计和Bland-Altman分析比较[11C]MTO和[18F]CETO预测手术结果。结果：169例患者中89例（52.7%）、78例（46.2%）和43例（25.4%）分别通过[11C]MTO、AVS或两者预测单侧PA。169例患者中有100例（59.1%）被多学科小组分配到肾上腺切除术；169例中有156例可获得主要结局数据。对完全或部分生化成功的预测最为准确([11C]MTO, 71.3% [95% CI， 61.0%至80.1%]；AVS, 62.8% [CI， 52.2%至72.6%])和最不准确的完全临床成功(家庭血压11C]MTO，但不是预先规定的下限-17%，允许[11C]MTO被宣布为不逊于AVS。[18F] 31例患者中有29例CETO和[11C]MTO符合（κ = 0.85 [CI, 0.68 ~ 1.00]）。局限性：[11C]MTO的准确性只能在手术组进行评估。结论：分子显像是一种准确、无创的AVS替代方法。主要资金来源：国家卫生和保健研究所。

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来源期刊

Annals of Internal Medicine 医学-医学：内科

CiteScore

23.90

自引率

1.80%

发文量

1136

审稿时长

3-8 weeks

期刊介绍： Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.