Burtnyk Mathieu, Hill Tracy, Cadieux-Pitre Heather, Welch Ian
Profound Medical, Inc., Toronto, Ontario, Canada; Animal Care and Veterinary Services, Western University (TH, HC-P, IW), London, Ontario, Canada.
Profound Medical, Inc., Toronto, Ontario, Canada; Animal Care and Veterinary Services, Western University (TH, HC-P, IW), London, Ontario, Canada.
J Urol. 2015 May;193(5):1669-75. doi: 10.1016/j.juro.2014.11.089. Epub 2014 Nov 22.
We determine the safety and feasibility of magnetic resonance image guided transurethral ultrasound prostate ablation using active temperature feedback control in a preclinical canine model with 28-day followup.
After a long acclimatization period we performed ultrasound treatment in 8 subjects using the magnetic resonance image guided TULSA-PRO™ transurethral ultrasound prostate ablation system. Comprehensive examinations and observations were done before and throughout the 28-day followup, including assessment of clinically significant treatment related adverse events. In addition to gross pathology evaluation, extensive histopathological analysis was done to assess cell kill inside and outside the prostate. We evaluated prostate conformal heating by comparing the spatial difference between the treatment plan and the 55C isotherm measured on magnetic resonance imaging thermometry acquired during treatment. These findings were confirmed on contrast enhanced magnetic resonance imaging immediately after treatment and at 28 days.
Clinically there were no adverse events in any of the 8 subjects throughout the 28-day followup. All subjects had normal urinary and bowel function. Gross necropsy and histology confirmed that the intended thermal cell kill was confined to the prostate. No surrounding tissue was damaged, including the rectum and the external urinary sphincter. Conformal heating was achieved with an average -0.9 mm accuracy and 0.9 mm precision. Contrast enhanced magnetic resonance imaging and histological analysis confirmed tissue ablation in targeted areas of the prostate. Urethral tissue was spared from thermal damage.
Magnetic resonance image guided transurethral ultrasound is a safe, feasible procedure for accurate and precise conformal thermal ablation of prostate tissue, as demonstrated in a preclinical model with 28-day followup.
我们在一个具有28天随访期的临床前犬类模型中，使用主动温度反馈控制来确定磁共振成像引导经尿道超声前列腺消融术的安全性和可行性。
经过长时间的适应期后，我们使用磁共振成像引导的TULSA-PRO™经尿道超声前列腺消融系统对8只受试动物进行了超声治疗。在28天随访期之前及整个过程中都进行了全面的检查和观察，包括评估具有临床意义的与治疗相关的不良事件。除大体病理学评估外，还进行了广泛的组织病理学分析，以评估前列腺内外的细胞杀伤情况。我们通过比较治疗计划与治疗期间获得的磁共振成像温度测量法所测得的55℃等温线之间的空间差异，来评估前列腺的适形加热情况。这些结果在治疗后即刻及28天时通过对比增强磁共振成像得到了证实。
在整个28天的随访期内，8只受试动物中无一出现临床不良事件。所有受试动物的泌尿和肠道功能均正常。大体尸检和组织学检查证实，预期的热细胞杀伤局限于前列腺。包括直肠和尿道外括约肌在内的周围组织均未受损。实现了适形加热，平均精度为-0.9毫米，精确性为0.9毫米。对比增强磁共振成像和组织学分析证实了前列腺靶向区域的组织消融。尿道组织未受到热损伤。
如在一个具有28天随访期的临床前模型中所证明的，磁共振成像引导经尿道超声是一种安全、可行的方法，可用于精确、准确地对前列腺组织进行适形热消融。
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