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FDA新批准的人工智能工具或有助于预测乳腺癌是否会复发New FDA-cleared AI tool could help predict if breast cancer will return

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一位女性正在接受三维乳腺X光检查的资料图片。Viacheslav Yakobchuk/Adobe StockStock photo of a woman undergoing a 3D mammogram. Viacheslav Yakobchuk/Adobe Stock

对于许多被诊断患有乳腺癌的女性来说,最大的担忧之一是治疗后癌症是否会复发。

For many women diagnosed with breast cancer, one of the biggest concerns is whether the cancer will return after treatment.

一款新获美国食品药品监督管理局(FDA)批准的人工智能工具可能帮助医生更早地回答这个问题。

A newly FDA-cleared artificial intelligence tool may help doctors answer that question earlier.

TumorSight Risk — 由SimBioSys开发并由NVIDIA技术驱动 — — 估计患者乳腺癌复发的概率,并且与许多当前检测不同,它可以在手术前提供此信息。

TumorSight Risk -- developed by SimBioSys and is powered by NVIDIA technology -- estimates the chance of a patient's breast cancer coming back, and unlike many current tests, it can give this information before undergoing surgery.

“对我们很多人来说,乳腺癌是个人化的。它影响着我们所爱的人。经过多年的AI创新,SimBioSys利用NVIDIA技术驱动其获FDA批准的TumorSight Risk,”NVIDIA医疗保健副总裁Kimberly Powell在接受ABC News独家首次技术展望采访时表示。

“For so many of us, breast cancer is personal. It touches people we love. After years of AI innovation, SimBioSys uses NVIDIA technology to power its FDA-cleared TumorSight Risk,” Kimberly Powell, vice president of healthcare at NVIDIA, told ABC News in an exclusive first look at the technology.

TumorSight Risk使用NVIDIA的图形处理单元(GPU),使得能够分析人类可能无法自行综合的复杂MRI数据和大量病史。

TumorSight Risk uses NVIDIA's Graphics Processing Units, allowing a process where complicated MRI data and reams of medical history that humans may not be able to synthesize on their own are analyzed.

这项新技术背后的公司正在与医疗保险(Medicare)、医疗补助(Medicaid)以及私人保险公司合作,以使该检测获得报销。

The company behind this new technology is working with Medicare, Medicaid, and private insurers to get the test covered.

一项新研究发现,人工智能工具可能帮助医生预测早期、激素受体阳性、HER2阴性乳腺癌女性的癌症复发风险。

A new study found that an AI tool may help doctors predict the risk of breast cancer returning in women with early-stage, hormone receptor-positive, HER2-negative breast cancer.

根据美国国家癌症研究所的数据,这种类型的乳腺癌约占美国所有乳腺癌诊断的74%。

This type of breast cancer accounts for approximately 74% of all breast cancer diagnoses in the United States, according to the National Cancer Institute.

“乳腺癌诊断后,女性提出的最大问题之一是,‘我的癌症复发的可能性有多大?’TumorSight Risk帮助医生回答这个问题,利用患者乳腺MRI中已有的信息,结合常规病理和临床信息,”SimBioSys总裁兼首席执行官Stacey Stevens在接受ABC News采访时表示。

“After a breast cancer diagnosis, one of the biggest questions women ask is, ‘What is the likelihood that my cancer will come back?’ TumorSight Risk helps doctors answer that question, using information already captured in a patient’s breast MRI, together with routine pathology and clinical information,” Stacey Stevens, president and CEO of SimBioSys, told ABC News.

该技术利用人工智能分析现有的乳腺MRI,以帮助估计女性癌症在五年甚至十年后复发的风险。

The technology uses AI to analyze an existing breast MRI to help estimate the risk of a woman’s cancer returning five or even ten years down the road.

研究人员分析了2129名女性的数据,发现被归类为低风险的女性中,95.5%的人在五年后仍无癌症复发,而高风险群体中这一比例为89.6%。

Researchers analyzed data from 2,129 women and found that 95.5% of those classified as low-risk remained cancer-free after five years, compared with 89.6% of those classified as high-risk.

他们分析了此前收集的患者信息,以确定人工智能是否能够识别出癌症复发风险更高的女性。与低风险群体相比,高风险群体的癌症复发风险高出三倍多。

They analyzed previously collected patient information to determine whether the AI could identify women at greater risk of their cancer returning. Those classified as high risk had more than three times the risk of their cancer returning compared to those with a low risk.

TumorSight Risk无需任何额外的扫描。相反,它利用患者在接受乳腺癌初步诊断时已经完成的乳腺MRI检查。

TumorSight Risk doesn’t require any additional scans. Instead, it uses the breast MRI a patient already had as part of their initial breast cancer diagnosis.

人工智能会分析MRI中的肿瘤及周围组织,然后将这些结果与患者的病理结果和临床信息相结合,生成一份个性化的评估报告,预测未来五到十年内癌症复发的可能性。该软件会生成一个从0到100的分数,将患者归类为低风险、中等风险或高风险。

AI examines the tumor and surrounding tissues on the MRI, then combines those findings with the patient’s pathology results and clinical information to generate a personalized estimate of how likely the cancer is to return over the next five to ten years. The software generates a score from zero to 100, classifying a patient as low, intermediate, or high risk.

“这一评估结果可以在手术前获得,让女性患者和医生在讨论治疗方案时能更早地掌握更多信息。我们的目标是帮助患者以更清晰、更自信的态度面对这些决策,”史蒂文斯说道。

“That insight can be available before surgery, giving women and their doctors more information, sooner, as they discuss treatment options. Our goal is to help patients face those decisions with greater clarity and confidence,” Stevens said.

研究人员还发现,人工智能生成的分数每增加10分,相对复发风险就会增加22%。

Researchers also found that each 10-point increase in the AI-generated score was associated with a 22% increase in relative recurrence risk.

“它将乳腺MRI提供的肿瘤及周围组织信息与临床数据相结合,有助于评估癌症复发的风险,从而帮助女性患者和医生根据每位患者的具体需求,做出更明智的医疗决策,”鲍威尔说道。

“It combines insights about a tumor and surrounding tissue from breast MRI with clinical information to help assess the risk of cancer returning—helping women and their doctors make more informed decisions about care tailored to each patient’s individual needs,” Powell said.

去年,SimBioSys开发了TumorSight Viz,该技术可将乳腺MRI转化为肿瘤的三维模型,为外科医生提供更清晰的可视化效果。

Last year, SimBioSys developed TumorSight Viz, which turns breast MRI into a 3D model of the tumor to give surgeons a clearer visualization.

医生会将TumorSight Risk评估结果与其他临床信息结合考虑,以确定治疗方案,帮助患者获得最佳医疗护理,并避免可能出现的严重副作用。

Doctors consider the TumorSight Risk assessment alongside other clinical information to land on treatment options, help patients get the best care available and avoid potentially significant side effects.

“TumorSight® Risk 或许能帮助我们结合现有检测方法和临床发现,构建更全面的病情图景。我们的目标是与每位患者共同权衡各种方案,同时考虑她的风险、潜在副作用以及个人优先事项,”Endeavor Health 的乳腺医学肿瘤科医生 Poornima Saha 医学博士在接受 ABC News 采访时说道。

“TumorSight® Risk may help us build a more complete picture alongside established tests and clinical findings. The goal is to weigh the options with each patient, taking her risk, potential side effects and personal priorities into account,” Poornima Saha, MD, a breast medical oncologist at Endeavor Health, told ABC News.

对部分女性而言,治疗可能包括手术、放疗、化疗或激素阻断药物,以降低癌症复发的可能性。

For some women, treatment may involve surgery, radiation, chemotherapy or hormone-blocking medications to reduce the chance of cancer returning.

“患者希望了解癌症复发的风险,以及治疗可能对其日常生活带来的影响,”Saha 表示。“对于激素受体阳性的乳腺癌,这类讨论可能远远超出初始治疗阶段,甚至包括是否需要在五年之后继续接受激素靶向治疗。”化疗和激素治疗等疗法可能伴随难以忍受的副作用,因此更清晰地了解复发风险,有助于医生判断哪些患者可能从治疗中受益。这项技术已开始在全国各地的医院和癌症中心投入使用。

“Patients want to understand both the risk of their cancer returning and what treatment could mean for their everyday lives,” Saha said. “For hormone receptor-positive breast cancer, those conversations can extend well beyond initial treatment, including whether to continue hormone-targeting therapy beyond five years.”Treatments like chemotherapy and hormone therapy can come with difficult side effects, so a clearer understanding of recurrence risk could help doctors identify which patients may benefit from treatment. The technology is starting to be used in hospitals and cancer centers nationwide.

对 TumorSight Risk 感兴趣的患者可以咨询自己的癌症治疗团队,了解其治疗中心是否提供这项服务,以及它是否适合自己的情况。

Patients who are curious about TumorSight Risk can ask their cancer care team whether it’s available at their treatment center and if it's right for them.