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
{"title":"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。","authors":"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","doi":"10.7326/ANNALS-24-00761","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To determine whether the accuracy of post-dexamethasone [<sup>11</sup>C]metomidate ([<sup>11</sup>C]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 [<sup>11</sup>C]MTO is interchangeable with its longer-half-life analogue, para-chloro-2-[<sup>18</sup>F]fluoroethyletomidate ([<sup>18</sup>F]CETO).</p><p><strong>Design: </strong>Prospective within-patient comparison of diagnostic interventions. (ClinicalTrials.gov: NCT02945904).</p><p><strong>Setting: </strong>Three referral centers.</p><p><strong>Participants: </strong>174 patients with PA desiring surgery if a unilateral source of PA was diagnosed.</p><p><strong>Intervention: </strong>[<sup>11</sup>C]MTO and AVS in 169 patients, plus [<sup>18</sup>F]CETO in the final 31.</p><p><strong>Measurements: </strong>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 [<sup>11</sup>C]MTO and [<sup>18</sup>F]CETO.</p><p><strong>Results: </strong>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 [<sup>11</sup>C]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 ([<sup>11</sup>C]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 [<sup>11</sup>C]MTO, but not the prespecified lower bound of -17%, allowing [<sup>11</sup>C]MTO to be declared noninferior to AVS. [<sup>18</sup>F]CETO and [<sup>11</sup>C]MTO agreed in 29 of 31 patients (κ = 0.85 [CI, 0.68 to 1.00]).</p><p><strong>Limitation: </strong>The accuracy of [<sup>11</sup>C]MTO could be assessed only in the surgical group.</p><p><strong>Conclusion: </strong>Molecular imaging is an accurate, noninvasive alternative to AVS.</p><p><strong>Primary funding source: </strong>National Institute for Health and Care Research.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"336-347"},"PeriodicalIF":19.6000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Molecular Imaging Versus Adrenal Vein Sampling for the Detection of Surgically Curable Primary Aldosteronism : A Prospective Within-Patient Trial.\",\"authors\":\"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\",\"doi\":\"10.7326/ANNALS-24-00761\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To determine whether the accuracy of post-dexamethasone [<sup>11</sup>C]metomidate ([<sup>11</sup>C]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 [<sup>11</sup>C]MTO is interchangeable with its longer-half-life analogue, para-chloro-2-[<sup>18</sup>F]fluoroethyletomidate ([<sup>18</sup>F]CETO).</p><p><strong>Design: </strong>Prospective within-patient comparison of diagnostic interventions. (ClinicalTrials.gov: NCT02945904).</p><p><strong>Setting: </strong>Three referral centers.</p><p><strong>Participants: </strong>174 patients with PA desiring surgery if a unilateral source of PA was diagnosed.</p><p><strong>Intervention: </strong>[<sup>11</sup>C]MTO and AVS in 169 patients, plus [<sup>18</sup>F]CETO in the final 31.</p><p><strong>Measurements: </strong>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 [<sup>11</sup>C]MTO and [<sup>18</sup>F]CETO.</p><p><strong>Results: </strong>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 [<sup>11</sup>C]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 ([<sup>11</sup>C]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 [<sup>11</sup>C]MTO, but not the prespecified lower bound of -17%, allowing [<sup>11</sup>C]MTO to be declared noninferior to AVS. [<sup>18</sup>F]CETO and [<sup>11</sup>C]MTO agreed in 29 of 31 patients (κ = 0.85 [CI, 0.68 to 1.00]).</p><p><strong>Limitation: </strong>The accuracy of [<sup>11</sup>C]MTO could be assessed only in the surgical group.</p><p><strong>Conclusion: </strong>Molecular imaging is an accurate, noninvasive alternative to AVS.</p><p><strong>Primary funding source: </strong>National Institute for Health and Care Research.</p>\",\"PeriodicalId\":7932,\"journal\":{\"name\":\"Annals of Internal Medicine\",\"volume\":\" \",\"pages\":\"336-347\"},\"PeriodicalIF\":19.6000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Internal Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.7326/ANNALS-24-00761\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/3/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Internal Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7326/ANNALS-24-00761","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/4 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Molecular Imaging Versus Adrenal Vein Sampling for the Detection of Surgically Curable Primary Aldosteronism : A Prospective Within-Patient Trial.
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.
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.
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