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IceCure's ProSense Chosen For Breast Cryoablation Study Led By The European Institute Of Oncology With Sponsorship From The Italian Ministry Of Health

IceCure's ProSense Chosen For Breast Cryoablation Study Led By The European Institute Of Oncology With Sponsorship From The Italian Ministry Of Health

IceCure的ProSense被欧洲肿瘤研究所选择用于乳腺冷冻消融研究,获得意大利卫生部的赞助。
Benzinga ·  11/19 08:32

PRECICE study, financed by the Umberto Veronesi Foundation and the Italian Ministry of Health, is led by multidisciplinary collaborators including breast surgeons, interventional radiologists, and breast imaging and pathology specialists

PRECICE研究由乌贝尔图·维罗内西基金会和意大利卫生部资助,由包括乳腺外科医生、介入放射科医生和乳腺影像学和病理学专家在内的多学科合作者领导。

PRECICE is exclusively using ProSense to treat all 233 Luminal A and B patients >50 years of age with early-stage breast cancer, a wider population of patients than ICE3

PRECICE专门使用ProSense治疗所有233名Luminal A和b类型的50岁以上早期乳腺癌患者,比ICE3的患者群范围更广。

Article published in European Journal of Cancer Prevention describes the PRECICE study and presents the role of cryoablation in the move toward de-escalation of surgical treatment

发表在《欧洲癌症预防杂志》上的文章描述了PRECICE研究,并展示了冷冻消融在朝向手术治疗降级的过程中的作用。

CAESAREA, Israel, Nov. 19, 2024 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ:ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced the publication of an article titled "Cryoablation of early breast cancer: the challenge towards de-escalation of surgical treatment" in the European Journal of Cancer Prevention.

以色列凯撒利亚,2024年11月19日 / PRNewswire / IceCure Medical Ltd.(纳斯达克:ICCM)(“IceCure”,“IceCure Medical”或“公司”),作为一家开发微创冷冻消融技术以冻结肿瘤作为替代手术切除的企业,今天宣布在《欧洲癌症预防杂志》上发表了一篇名为“早期乳腺癌的冷冻消融:朝向手术治疗降级的挑战”的文章。

The article, authored by breast surgeons and interventional radiologists including Director of Interventional Radiology at the European Institute of Oncology in Milan, Italy, Franco Orsi, MD, presents a review of recent studies and literature on cryoablation of breast cancer, stating:

该文章作者包括位于意大利米兰欧洲肿瘤研究所介入放射科主任、董事弗朗科·奥尔西博士(Franco Orsi, MD),提供了一篇关于乳腺癌冷冻消融的近期研究和文献综述。

"The scientific assumption moving researchers is that cryoablation could represent a precise and safe alternative to the surgery itself for a selected subgroup of women."

“驱使研究人员努力的科学假设是,对于一部分女性群体而言,冷冻消融可能是手术的精确安全替代。”

The article highlights the Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECICE) study, led by Principal Investigator, Dr. Orsi. PRECICE is an independent prospective observational 233 patient study that has commenced the enrollment of women 50 years of age and older with unifocal, small (up to 15 mm in diameter), clinically node-negative, luminal A and B breast cancer.

该文章重点介绍了由首席研究员奥尔西博士领导的低风险早期乳腺癌经皮冷冻消融(PRECICE)研究。PRECICE是一项独立的前瞻性观察研究,已开始招募50岁及以上年龄的单焦点、直径不超过15毫米、临床无淋巴结转移的Luminal A和b型乳腺癌患者。

The PRECICE study, which will exclusively use ProSense to conduct all procedures, will evaluate the technical effectiveness of cryoablation with a median follow-up of five years (with early primary and secondary outcomes after three years). The procedure failure rate will be evaluated for possible residual tumor by mammography, ultrasound, and nuclear MRI at two months before radiotherapy and six months after radiotherapy. If relapse is suspected, an image-guided breast biopsy will be performed. Additional endpoints including quality of life, psychological impact, and economic outcomes will also be evaluated.

PRECICE研究将仅使用ProSense进行所有操作,评估冷冻消融的技术有效性,随访时间中值为五年(在三年后获得早期主要和次要结果)。手术失败率将通过乳腺X线摄影、超声波和核磁共振成像在放疗前两个月和放疗后六个月对可能残留肿瘤进行评估。如有疑似复发,将进行图像引导的乳腺活检。还将评估包括生活质量、心理影响和经济结果在内的其他终点。

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