Treatment of Primary Solid Renal Tumours Using Histotripsy: Study Protocol for the CAIN Feasibility Trial.

IF 2.8 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

CardioVascular and Interventional Radiology Pub Date : 2025-06-01 Epub Date: 2025-04-28 DOI:10.1007/s00270-025-04035-5

Tze Min Wah, Joseph F Amaral, Paul F Laeseke

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引用次数: 0

Abstract

Purpose: 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.

Methods/design: The CAIN trial will enrol up to 20 patients with a non-metastatic solid renal tumour ≤ 3 cm 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 ≤ 36 h 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 days after the last histotripsy procedure. Treated patients will have a follow-up visit performed at 14 days, 30 days, 90 days, and 180 days post-procedure.

Trial registration: Clinicaltrials.gov identifier NCT05432232 & NIHR CRN CPMS 53429.

查看原文本刊更多论文

使用组织切片法治疗原发性实体肾肿瘤：CAIN可行性试验的研究方案。

目的：这项前瞻性、多中心、单臂可行性试验的目的是评估组织声学系统使用组织切片法治疗原发性实体肾肿瘤的技术成功和安全性。方法/设计：CAIN试验将招募20例≤3cm的非转移性实体肾肿瘤患者，并进行组织学检查。组织切片术是一种非热和非电离的组织破坏机械过程，由聚焦超声脉冲的靶向传递引起。主要终点是技术上的成功和与手术相关的主要并发症的自由。技术上的成功定义为通过对比增强磁共振成像（MRI）或计算机断层扫描（CT）在索引后≤36小时确定肿瘤的完全覆盖。与主要并发症相关的指标手术被定义为Clavien-Dindo分级3级或以上，直至最后一次组织切片手术后30天。接受治疗的患者将在术后14天、30天、90天和180天进行随访。试验注册：Clinicaltrials.gov识别码NCT05432232和NIHR CRN CPMS 53429。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

CardioVascular and Interventional Radiology 医学-核医学

CiteScore

5.50

自引率

13.80%

发文量

306

审稿时长

3-8 weeks

期刊介绍： CardioVascular and Interventional Radiology (CVIR) is the official journal of the Cardiovascular and Interventional Radiological Society of Europe, and is also the official organ of a number of additional distinguished national and international interventional radiological societies. CVIR publishes double blinded peer-reviewed original research work including clinical and laboratory investigations, technical notes, case reports, works in progress, and letters to the editor, as well as review articles, pictorial essays, editorials, and special invited submissions in the field of vascular and interventional radiology. Beside the communication of the latest research results in this field, it is also the aim of CVIR to support continuous medical education. Articles that are accepted for publication are done so with the understanding that they, or their substantive contents, have not been and will not be submitted to any other publication.