{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T01:44:37Z","timestamp":1791855877888,"version":"4.3.4"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T00:00:00Z","timestamp":1745798400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T00:00:00Z","timestamp":1745798400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"HistoSonics"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cardiovasc Intervent Radiol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>The purpose of this prospective, multi-centre, single-arm feasibility trial is to evaluate the technical success and safety profile of the HistoSonics System for the treatment of primary solid renal tumours using histotripsy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>The CAIN trial will enrol up to 20 patients with a non-metastatic solid renal tumour\u2009\u2264\u20093\u00a0cm treated with histotripsy. Histotripsy is a non-thermal and non-ionizing mechanical process of tissue destruction resulting from the targeted delivery of focused ultrasound pulses. The primary endpoints are technical success and freedom from index procedure related major complications. Technical success is defined as complete coverage of the tumour as determined\u2009\u2264\u200936\u00a0h post-index procedure by contrast-enhanced magnetic resonance imaging (MRI) or computerized tomography (CT). An index procedure related major complication is defined as Clavien-Dindo Classification Grade 3 or higher up to 30\u00a0days after the last histotripsy procedure. Treated patients will have a follow-up visit performed at 14\u00a0days, 30\u00a0days, 90\u00a0days, and 180\u00a0days post-procedure.<\/jats:p>\n                    <jats:p>\n                      <jats:italic>Trial Registration<\/jats:italic>\n                      : Clinicaltrials.gov identifier NCT05432232 &amp; NIHR CRN CPMS 53429.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical Abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s00270-025-04035-5","type":"journal-article","created":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T17:15:50Z","timestamp":1745860550000},"page":"857-865","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Treatment of Primary Solid Renal Tumours Using Histotripsy: Study Protocol for the CAIN Feasibility Trial"],"prefix":"10.1007","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5670-5454","authenticated-orcid":false,"given":"Tze Min","family":"Wah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph F.","family":"Amaral","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul F.","family":"Laeseke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,4,28]]},"reference":[{"key":"4035_CR1","doi-asserted-by":"publisher","first-page":"79","DOI":"10.14740\/wjon1279","volume":"11","author":"SA Padala","year":"2020","unstructured":"Padala SA, Barsouk A, Thandra KC, Saginala K, Mohammed A, Vakiti A, et al. Epidemiology of renal cell carcinoma. World J Oncol. 2020;11:79\u201387.","journal-title":"World J Oncol"},{"key":"4035_CR2","doi-asserted-by":"publisher","first-page":"520","DOI":"10.1016\/j.juro.2017.04.100","volume":"198","author":"S Campbell","year":"2017","unstructured":"Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, et al. Renal mass and localized renal cancer: AUA guideline. J Urol. 2017;198:520\u20139.","journal-title":"J Urol"},{"key":"4035_CR3","unstructured":"NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer [Internet]. 2025 Jan. Report No.: Version 3.2025. Available from: https:\/\/www.nccn.org\/guidelines\/guidelines-detail?category=1&id=1440"},{"key":"4035_CR4","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1080\/02656736.2019.1647352","volume":"36","author":"D Filippiadis","year":"2019","unstructured":"Filippiadis D, Mauri G, Marra P, Charalampopoulos G, Gennaro N, De Cobelli F. 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J Vasc Interv Radiol. 2019;30:1293\u2013302.","journal-title":"J Vasc Interv Radiol"},{"key":"4035_CR9","doi-asserted-by":"publisher","first-page":"1986","DOI":"10.1016\/j.jvir.2023.07.014","volume":"34","author":"AB Couillard","year":"2023","unstructured":"Couillard AB, Zlevor AM, Ziemlewicz TJ, Kisting MA, Knott E, Rossebo AE, et al. A comparison of histotripsy and percutaneous cryoablation in a chronic healthy swine kidney model. J Vasc Interv Radiol JVIR. 2023;34:1986\u201396.","journal-title":"J Vasc Interv Radiol JVIR"},{"key":"4035_CR10","doi-asserted-by":"publisher","first-page":"2272065","DOI":"10.1080\/02656736.2023.2272065","volume":"40","author":"KL Falk","year":"2023","unstructured":"Falk KL, Laeseke PF, Kisting MA, Zlevor AM, Knott EA, Smolock AR, et al. Clinical translation of abdominal histotripsy: a review of preclinical studies in large animal models. Int J Hyperth. 2023;40:2272065.","journal-title":"Int J Hyperth"},{"key":"4035_CR11","doi-asserted-by":"publisher","first-page":"e233051","DOI":"10.1148\/radiol.233051","volume":"312","author":"M Mendiratta-Lala","year":"2024","unstructured":"Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Cr\u00e9ixams X, White SB, Davis C, et al. The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors. Radiology. 2024;312:e233051.","journal-title":"Radiology"},{"key":"4035_CR12","doi-asserted-by":"publisher","first-page":"1888","DOI":"10.1121\/1.3625239","volume":"130","author":"AD Maxwell","year":"2011","unstructured":"Maxwell AD, Wang T-Y, Cain CA, Fowlkes JB, Sapozhnikov OA, Bailey MR, et al. Cavitation clouds created by shock scattering from bubbles during histotripsy. J Acoust Soc Am. 2011;130:1888\u201398.","journal-title":"J Acoust Soc Am"},{"key":"4035_CR13","unstructured":"HistoSonics, Inc. 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Research grants from Boston Scientific, HistoSonics, and Johnson & Johnson; education grant from Angiodynamics. J.F.A. Chief Medical Officer of Venture Investors, an investor in Histosonics. P.F.L. HistoSonics (consultant, shareholder, sponsored research agreement), NeuWave\/Ethicon\/Johnson&Johnson (Consultant).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}