Deborah Rhodes:有效發現乳房腫瘤工具，為什麼不是提供給您

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Deborah Rhodes:有效發現乳房腫瘤工具，為什麼不是提供給您
在乳腺X光造影诊断中， 有两类女性： X光造影诊断对其中一类十分有效， 已经拯救了数千条生命； 但对另一类却无法做出有效诊断。 你是否知道你是哪一类？ 你并非唯一不了解的人。 因为乳房已经成为 一种非常政治化的器官。 真相正日渐式微， 淹没于各大媒体、 政治家、 放射学家、 以及医学成像公司的虚夸雄辩。 今天早上，我将尽自己最大的努力 告诉你们我所认为的真相。 但首先我必须坦白， 我不曾战胜过乳腺癌。 我也不是放射学家。 我没有任何专利， 我也从未从任何一家医学造影公司拿过一分钱。 而且我并不期待你们的投票。
（笑声）
我只是 一位内服药品医生， 大约十年前， 一个病人的问题 让我对这个领域产生了浓厚的兴趣。 她来见我 她刚被诊断出一个乳房肿块。 她的姐姐在四十岁时， 被诊断为乳腺癌。 当时她和我都已经是大腹便便的孕妇了， 我为她感到心痛， 我想她该有多担心害怕。 幸运的是，她的肿块是良性的。 但她问了我一个问题： 我有多大的把握 能在她的乳房X光片中 发现早期肿瘤？ 于是我仔细看了她的乳房X光片， 我查阅了放射学文献， 我震惊地发现， 在她的情况下， 在乳房X光片中发现早期肿瘤的可能性， 竟然小于50%.
你大概可以想起来，一年前 那次大爆发， 美国预防服务工作组 审查了全球乳房X光造影诊断技术的文献， 发布了一个准则 表示不推荐四十岁的女性 使用乳房X光造影诊断。 然后所有人都指责工作组， 即使他们中根本没有人 真的了解乳房X光造影诊断。 参议院又花了17天， 禁止在保险覆盖条例中 使用这个条例。 放射学家对这个条例 十分愤慨。 美国最杰出的乳房X光造影技术专家 在华盛顿邮报上 发表声明。 放射学家反被指责 过分关注个人经济利益。 然而我认为， 这些放射学家才是真英雄。 一直以来，有资质看乳房X光片的 放射学家是不多的， 因为解读乳房X光片是 所有放射性研究中最为复杂的， 另外相比其他原因， 放射学家更容易因此 而被指控 误诊乳腺癌。 但事实胜于雄辩。
哪里有硝烟， 哪里就有烈火。 导致这场激辩烈火的重要因素， 是乳腺密度。 乳腺密度是指脂肪含量- （图中黄色的部分）-- 与结缔组织含量（图中粉色部分）-- 的比例。 这个比例 主要是由基因决定的。 2/3的四十岁女性 属于高乳腺密度， 这就是为什么乳房X光造影技术无法对他们做出有效诊断的原因。 尽管乳腺密度一般随年龄增长而下降， 仍有1/3的女性 在停经数年后 仍属于高乳腺密度的群体。
那你该如何知道你是否属于高乳腺密度呢？ 你需要非常仔细地阅读 你的乳房X光片报告。 放射学家 根据乳腺组织的成像 将乳腺密度分为四类。 乳腺密度小于25%， 称为脂肪替代型； 第二种 是分散乳腺纤维密度型； 然后是混合密度型， 极极高密度型。 最后两类， 是高密度型的。 高密度乳腺所带来的问题 就好像披着羊皮的狼。 肿瘤和高密度乳腺组织 在乳房X光片上都呈现为白色， 通常X光无法辨别这两者。 所以很容易 在此处上部的脂肪组织中看到肿瘤。 但你无法想象 在高密度乳腺中找到肿瘤是多么困难。 这就是为什么，乳房X光造影成像技术 可以在低乳腺密度的乳房中找到80%以上的肿瘤， 而在极高乳腺密度的乳房中只能找到40%。
好吧，高乳腺密度已经导致 寻找肿瘤比其它情况更困难， 然而更糟的是， 高乳腺密度也有力地指向 乳腺癌患病率的高风险。 它的风险系数 比母亲或姐妹有乳腺癌病史更强。 当年我的病人问我这个问题时， 乳腺密度在放射性学的学术界 还未引起重视， 很少有接受乳房X光造影诊断的女性， 或者使用乳房X光造影诊断的内科医生 了解这一点。 但我又能为她做些什么？
乳房X光造影诊断于1960年前后开始流行， 此后几乎没有什么改进。 几乎没有令人震惊的创新， 直到2000年， 数码乳房X光造影技术被批准进入市场。 数码乳房X光造影仍然使用X光， 但是图像 可以储存并进行数码操纵， 就像我们用数码相机一样。 美国已经投入 40亿美元 更新换代至数码乳房X光造影设备。 我们又从这笔投资中得到了什么呢？ 一项耗费纳税人两千五百万美金的调查显示， 数码乳房X光仪 并不比传统设备 有更优的综合表现。 事实上，对老年女性来说，表现更糟。 不过， 对50岁以下女性来说，表现更好， 这一群体还未停经，且乳腺组织密度较高。 在这个群体中， 数码乳房X光诊断可以找到两倍多的肿瘤， 尽管仍只有60%。 所以数码乳房X光造影技术 对数码乳房X光造影设备的 制造商来说， 是一次巨大的飞跃， 但对女性来说， 却只是一小步而已。
那么超声波呢？ 与其他技术相比，超声波检查必须配合 更多不必要的活组织检查， 所以并未得到广泛使用。 核磁共振在肿瘤诊断方面相当灵敏， 但它也非常昂贵。 联想到其他领域的各种科技， 可以发现一种普遍存在的模式， 就是它们总是像更小、更经济的方向发展。 比较一下iPod和立体声音响吧。 但在医疗保健领域，情况则完全相反。 设备越来越大， 越来越昂贵。 女性做一次核磁共振扫描， 就像驾着悍马轰隆隆进杂货店一样。 杀鸡用牛刀。 一次核磁共振扫描， 价格约为数码X光造影的10倍。 迟早我们会接受这个现实： 医疗保健领域的创新 不可能总是如此价格高昂。
Malcolm Gladwell在纽约人上写过一篇 有关创新的文章， 他认为科学发现 绝非个人天才的产品， 反之，伟大的思想可以和谐交融， 如果你能把 持有各种观点的人集中在一个房间内， 让他们就一般不会谈及的事务 充分交流沟通， 这其实就类似于TED的精髓了。 他引用一位创新者的话： “只有一种情况能让内科医生和物理学家见面， 就是物理学家病了。” （笑声） 这说法很不对， 因为物理学家一直以来都没有意识到 他们的很多问题都是有解决办法的。 内科医生也没有意识到 他们正可以提供许多问题的解法。 看这副漫画 Gladwell在文章中也引用过它， 告诉我这幅画对创新者的描绘， 是否让你感到有些困惑。
（笑声）
如果你们不介意我发挥一点创造力， 我要告诉你们一个 极其偶然的巧合， 有关我病人的问题 和一个医生的解决办法。 在她拜访我之后不久， 我认识了一位核物理学家， 他来自Mayo(译者注：梅奥，爱尔兰西北一郡) 名叫Michael O'Conner， 是心血管造影的专家， 我对心血管造影那是一窍不通， 一个偶然，他告诉我 他刚从以色列开会回来， 他们正讨论某种悉心伽马探测器， 伽马线造影已经出现有段时间了， 一直被用于心脏造影， 也曾有人尝试将其用于乳房造影。 但问题是 伽马线的探测器 是这种块头巨大的显像管， 里面塞满这样亮晶晶的晶状物 你根本没有办法把它们放到距离乳房足够近的地方， 去找到小肿瘤。 但隐性的优势在于 伽马射线与X射线不同， 并不会被乳腺密度影响。 但这项技术 没有办法找到小型的肿瘤。 找到小型肿瘤对存活率非常关键。 如果你能找到一个 直径小于1厘米的肿瘤， 存活率超过90%， 之后存活率随着 肿瘤增大而迅速下降。 Michael告诉我， 他见到的一种新型伽马探测器， 就是这个东西。 它并非 由巨大的晶体管造成， 取而代之的是一层轻薄的半导体材料， 来作为伽马线探测器。 于是我开始与他讨论 乳腺密度的问题， 我们意识到也许我们可以 把这个探测器放到距离乳房足够近的地方 去找到小肿瘤。
接着我们 用胶带纸把这些小方块粘在一起--
（笑声） --Michael去掉了一台 即将废弃的乳房X光仪上的 X射线板。 我们连上新的探测器， 我们决定称这台机器为 分子乳房造影，简称MBI。 这是我们第一位病人的造影片。 可以看到，使用古老的伽马线探测技术， 看起来一片模糊。 但如果使用新的探测器， 我们可以看到肿瘤的边界。
于是我们，一个核物理学家， 一个内科医师， 之后Carrie Hruska又加入我们，一位生物医学工程师， 还有两位放射学家， 我们尝试使用一台用胶布粘起来的仪器， 去拓展 造影成像技术的世界。 要说我们在早年 面对了 大量的嘲讽 都只能说是轻描淡写了。 但我们都坚信我们一定会成功 我们一点一点 改进整个系统。 这是我们目前的探测器， 你会发现它看起来已经非常不同。 没有胶布了， 我们在乳房上方加入第二块探测器， 进一步改进了我们侦测肿瘤的能力。
它实际作用如何？ 这位病人注射了放射性跟踪剂， 繁殖旺盛的肿瘤细胞会迅速吸收这种放射性跟踪剂， 正常细胞则不会。 这里显示造影片的巨大区别。 造影技术依靠的就是 肿瘤组织与周边组织的外貌区别， 我们看到这种区别 在高乳腺密度的乳房中很模糊。 但是MBI完整表现了 肿瘤与其他细胞的区别， 因此不受乳腺密度的影响。 在注射后， 这位病人的乳房被置于两篇探测器中间。 如果你曾做过乳房X光造影诊断-- 如果你年龄足够大的话-- 你知道随之而来的是： 疼痛。 你也许会很惊讶， 乳房X光造影 是唯一被联邦法律允许的放射性研究技术， 法律要求 其强度约等于一块40磅的汽车电池 砸重你的乳房。 但是用MBI， 只有轻微的压痛感。
（掌声） 探测器 把图像传回点奥。
这是一个例子。 你可以看到右侧，X光片 显示一个模糊地肿瘤， 肿瘤边缘由于高密度乳腺组织而变得模糊。 但MBI成像中的肿瘤，清楚多了， 还有第二个肿瘤， 这对病人的手术方案有巨大的影响。 在这个例子中，X光片找到了一个肿瘤， 但我们找到了3个独立的肿瘤-- 其中一个直径只有3毫米。
我们的突破在2004年。 在我们论证能找到小肿瘤之后， 我们用这些图像 声请Susan G.Komen基金会的赞助。 当他们最终决定在一群未曾谋面的探索者身上冒这个险时， 我们是那么的欢欣鼓舞， 他们赞助我们 研究1000名高乳腺密度的女性， 并比较她们的X光片和MBI成像。 在所有我们找到的肿瘤中， X光片找到了其中的 25% MBI找到了83%。 这是此次扫描研究的例表。 数码X光片如往常一样， 显示大量高密度乳腺组织， 但是MBI显示了一片高密度区域， 该区域与一个直径2厘米的肿瘤有关。 在这个例子中，一个直径1厘米的肿瘤。 这个例子， 一位来自梅奥的45岁医学秘书， 她很小时母亲就患乳腺癌去世了， 因此她希望参与我们的研究。 她的X光片显示一片高密度乳腺组织， 而她的MBI显示 该区域值得忧虑， 在彩片中也可以看到。 与此对应的 是一个高尔夫球大小的肿瘤。 幸运的是我们摘除了它， 当时它还未扩散到淋巴结。
所以现在我们得知这项技术 可以在高乳腺密度的乳房中找到3倍多的肿瘤， 还有一个很重要的问题需要解决。 我们必须尝试降低放射量。 最近这三年， 我们对这个造影系统地每一个细节都做了改进， 致力于降低它的放射量。 我现在非常高兴地告诉大家，我们现在使用的放射量 已经与数码X光造影的有效放射量 完全相等。 使用低放射量，我们继续这项扫描研究， 这张图片，来自于3周前， 一位67岁的妇女， 其数码X光片显示一切正常， 但是MBI图像显示 这是一大片癌细胞，之后也被验证确实如此。 所以这不仅仅是有益于低年龄层女性了。 高年龄层的、乳腺密度较高的女性同样受益。 现在我们一般只使用，1/5于 其他类型伽马射线技术的放射量。
MBI对每个乳房呈现4张图像。 MRI贺词公正则呈现超过1000长。 一个放射学家 需要很多年专业训练 才能成为辨别 普通解剖学细节组织 和真正病灶的专家。 但我猜想，这个房间里，即使你不是一位放射学专家， 你也可以在MBI成像中找到肿瘤。 然而这正是MBI 受到百般阻挠的原因。 它和核磁共振一样精确， 但又比核磁共振好辨认的多， 而且花费只是核磁共振的一个零头。 也许你能明白为什么 在乳房成像领域中， 有些人却安于现状。
在获得这个我们自认为非凡的成就之后， 我们的手稿 被4家杂志拒收。 在第四次拒收后， 我们要求对手稿进行重审， 因为我们严重怀疑 审核小组中一位拒绝此手稿的成员 在与之竞争的技术领域 有经济利益纠葛。 之后我们的手稿被接收了 并即将在本月末刊登在 《放射学研究》中。 （掌声） 我们继续用低放射量完成整个扫描研究， 然后我们的成果将需要 其它研究机构重新检验。 这可能会耗费五年或更长时间。 如果这项技术被广泛运用， 我不会获得任何经济利益。 这对我很重要， 因为这一点让我坚持告诉你们真相。 但我意识到--
（掌声） 我意识到要推广这项技术， 不仅需要强大的技术支持， 也需要经济力量 和政治力量的支持。
MBI已经被FDA批准了， 但仍未被广泛运用。 因此在MBI面世之前， 对于高乳腺密度的女性， 有些东西你们需要了解 来保护你们自己。 第一，了解你的乳腺密度。 90%的女性不了解自己的乳腺密度， 95%的女性不了解 乳腺密度的增加也会增加罹患乳腺癌的风险 康涅狄格州成为第一个，也是唯一一个 要求女性在乳房X光片诊断后 了解 自己乳腺密度的州。 上周在芝加哥，我参加了一个 6万人与会的乳房造影技术大会。 我惊讶于看到一场激烈地辩论， 关于是否应该告诉女性 她们的乳腺密度。 我们当然应该告诉她们。 如果你不知道，请询问你的一生 或者仔细研究你的乳房X光诊断报告。 第二，如果你还未绝经， 请尝试把你的乳房X光诊断 计划在月经周期的前两周， 这段时间你的乳腺密度相对较低。 第三，如果你注意到你的乳房有一些慢性病变， 请坚持要求更多的检查。 第四，也是最重要的一点， 乳房X光诊断的辩论将会持续升温， 但我坚信40岁以上的女性应该每年做一次 乳房X光检查。
乳房X光检查并不完美， 但它是目前为止唯一被验证 可以降低乳腺癌死亡率的诊断方式。 但这个死亡率招牌 正是一把双刃剑， 乳房X光诊断的热诚簇拥者们用这把剑 来打击创新。 而另一些身患乳腺癌的女性 多年后却因它而死。 谢天谢地的是，大部分女性，活了下来。 还有10年， 才能出现一个新的造影成像技术 带来一次 乳腺癌死亡率的下降。 长久以来，乳房X光造影 是唯一有机会声明它可以降低乳腺癌死亡率的。 但现在是时候让我们接受 乳房X光造影不仅有非凡的成功之处， 也存在许多限制。 我们需要对不同乳腺密度的个体 使用个性化的扫描成像技术。 对于低乳腺密度的女性来说， 乳房X光造影是最佳选择。 但对于高乳腺密度的女性来说， 我们不该一刀子斩断所有的造影诊断技术， 我们要为她们提供更好的诊断技术。
当年我的病人问我问题时 我们怀着的孩子， 如今已双双进入中学， 答案却迟迟未来。 她给我祝福， 让我把这个故事与你们分享。 在接受活组织检查后， 而活组织检查会增加患癌症风险， 以及经历被癌症夺去妹妹的痛苦之后， 她终于做出了艰难的决定， 为避免乳腺癌而做了乳房切除术。 我们有能力，并且必须做的更好， 这不仅是为了她的孙代， 还有我的女儿， 还有在座的各位。
谢谢。
（掌声）

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Deborah Rhodes: A tool that finds 3x more breast tumors, and why it's not available to you
There are two groups of women when it comes to screening mammography -- women in whom mammography works very well and has saved thousands of lives and women in whom it doesn't work well at all. Do you know which group you're in? If you don't, you're not alone. Because the breast has become are very political organ. The truth has become lost in all the rhetoric coming from the press, politicians, radiologists and medical imaging companies. I will do my best this morning to tell you what I think is the truth. But first, my disclosures. I am not a breast cancer survivor. I'm not a radiologist. I don't have any patents, and I've never received any money from a medical imaging company. And I am not seeking your vote.

(Laughter)

What I am is a doctor of internal medicine who became passionately interested in this topic about 10 years ago when a patient asked me a question. She came to see me after discovering a breast lump. Her sister had been diagnosed with breast cancer in her forties. She and I were both very pregnant at that time, and my heart just ached for her, imagining how afraid she must be. Fortunately, her lump proved to be benign. But she asked me a question: how confident was I that I would find a tumor early on her mammogram if she developed one? So I studied her mammogram, and I reviewed the radiology literature, and I was shocked to discover that, in her case, our chances of finding a tumor early on the mammogram were less than the toss of a coin.

You may recall a year ago when a firestorm erupted after the United States Preventive Services Task Force reviewed the world's mammography screening literature and issued a guideline recommending against screening mammograms in women in their forties. Now everybody rushed to criticize the task force, even though most of them weren't in anyway familiar with the mammography studies. It took the Senate just 17 days to ban the use of the guidelines in determining insurance coverage. Radiologists were outraged by the guidelines. The preeminent mammographer in the United States issued the following quote to the Washington Post. The radiologists were in turn criticized for protecting their own financial self-interest. But in my view, the radiologists are heroes. There's a shortage of radiologists qualified to read mammograms, and that's because mammograms are one of the most complex of all radiology studies to interpret, and because radiologists are sued more often over missed breast cancer than any other cause. But that very fact is telling.

Where there is this much legal smoke, there is likely to be some fire. The factor most responsible for that fire is breast density. Breast density refers to the relative amount of fat -- pictured here in yellow -- versus connective and epithelial tissues -- pictured in pink. And that proportion is primarily genetically determined. Two-thirds of women in their forties have dense breast tissue, which is why mammography doesn't work as well in them. And although breast density generally declines with age, up to a third of women retain dense breast tissue for years after menopause.

So how do you know if your breasts are dense? Well, you need to read the details of your mammography report. Radiologists classify breast density into four categories based on the appearance of the tissue on a mammogram. If the breast is less than 25 percent dense, that's called fatty replaced. The next category is scattered fibroglandular densities, followed by heterogeneously dense and extremely dense. And breast that fall into these two categories are considered dense. The problem with breast density is that it's truly the wolf in sheep's clothing. Both tumors and dense breast tissue appear white on a mammogram, and the X-ray often can't distinguish between the two. So it's easy to see this tumor in the upper part of this fatty breast. But imagine how difficult it would be to find that tumor in this dense breast. That's why mammograms find over 80 percent of tumors in fatty breasts, but as few as 40 percent in extremely dense breasts.

Now it's bad enough that breast density makes it hard to find a cancer, but it turns out that it's also a powerful predictor of your risk for breast cancer. It's a stronger risk factor than having a mother or a sister with breast cancer. At the time my patient posed this question to me, breast density was an obscure topic in the radiology literature, and very few women having mammograms, or the physicians ordering them, knew about this. But what else could I offer her?

Mammograms have been around since the 1960's. And it's changed very little. There have been surprisingly few innovations, until digital mammography was approved in 2000. Digital mammography is still an X-ray of the breast, but the images can be stored and manipulated digitally, just like we can with a digital camera. The U.S. has invested four billion dollars converting to digital mammography equipment. And what have we gained from that investment? In a study funded by over 25 million taxpayer dollars, digital mammography was found to be no better over all than traditional mammography. And in fact, it was worse in older women. But it was better in one group, and that was women under 50 who were pre-menopausal and had dense breasts. And in those women, digital mammography found twice as many cancers, but it still only found 60 percent. So digital mammography has been a giant leap forward for manufacturers of digital mammography equipment, but it's been a very small step forward for womankind.

What about ultrasound? Ultrasound generates more biopsies that are unnecessary relative to other technologies, so it's not widely used. And MRI is exquisitely sensitive for finding tumors, but it's also very expensive. If we think about disruptive technology, we see an almost ubiquitous pattern of the technology getting smaller and less expensive. Think about iPods compared to stereos. But it's the exact opposite in health care. The machines get ever bigger and ever more expensive. Screening the average young woman with an MRI is kind of like driving to the grocery store in a Hummer. It's just way too much equipment. One MRI scan costs 10 times what a digital mammogram costs. And sooner or later, we're going to have to accept the fact that health care innovation can't always come at a much higher price.

Malcolm Gladwell wrote an article in the New Yorker on innovation, and he made the case that scientific discoveries are rarely the product of one individual's genius. Rather, big ideas can be orchestrated, if you can simply gather people with different perspectives in a room and get them to talk about things that they don't ordinarily talk about. It's like the essence of TED. He quotes one innovator who says, "The only time a physician and a physicist get together is when the physicist gets sick." (Laughter) This makes no sense, because physicians have all kinds of problems that they don't realize have solutions. And physicists have all kinds of solutions for things that they don't realize are problems. Now, take a look at this cartoon that accompanied Gladwell's article, and tell me if you see something disturbing about this depiction of innovative thinkers.

(Laughter)

So if you will allow me a little creative license, I will tell you the story of the serendipitous collision of my patient's problem with a physicist's solution. Shortly after her visit, I was introduced to a nuclear physicist at Mayo named Michael O'Conner, who was a specialist in cardiac imaging, something I had nothing to do with. And he happened to tell me about a conference he'd just returned from in Israel, where they were talking about a new type of gamma detector. Now gamma imaging has been around for a long time to image the heart, and it had even been tried to image the breast. But the problem was that the gamma detectors were these huge, bulky tubes, and they were filled with these scintillating crystals, and you just couldn't get them close enough around the breast to find small tumors. But the potential advantage was that gamma rays, unlike X-rays, are not influenced by breast density. But this technology could not find tumors when they're small. And finding a small tumor is critical for survival. If you can find a tumor when it's less than a centimeter, survival exceeds 90 percent, but drops off rapidly as tumor size increases. But Michael told me about a new type of gamma detector that he'd seen, and this is it. It's made, not of a bulky tube, but of a thin layer of a semiconductor material that serves as the gamma detector. And I started talking to him about this problem of breast density, and we realized that we might be able to get this detector close enough around the breast to actually find small tumors.

So after putting together a grid of these cubes with tape -- (Laughter) -- Michael hacked off the X-ray plate of a mammography machine that was about to be thrown out. And we attached the new detector, and we decided to call this machine Molecular Breast Imaging, or MBI. This is an image from our first patient. And you can see, using the old gamma technology, that it just looked like noise. But using our new detector, we could begin to see the outline of a tumor.

So here we were, a nuclear physicist, an internist, soon joined by Carrie Hruska, a biomedical engineer, and two radiologists, and we were trying to take on the entrenched world of mammography with a machine that was held together by duct tape. To say that we faced high doses of skepticism in those early years is just a huge understatement. But we were so convinced that we might be able to make this work that we chipped away with incremental modifications to this system. This is our current detector. And you can see that it looks a lot different. The duct tape is gone, and we added a second detector on top of the breast, which has further improved our tumor detection.

So how does this work? The patient receives an injection of a radio tracer that's taken up by rapidly proliferating tumor cells, but not by normal cells. And this is the key difference from mammography. Mammography relies on differences in the appearance of the tumor from the background tissue, and we've seen that those differences can be obscured in a dense breast. But MBI exploits the different molecular behavior of tumors, and therefore, it's impervious to breast density. After the injection, the patient's breast is placed between the detectors. And if you've ever had a mammogram -- if you're old enough to have had a mammogram -- you know what comes next: pain. You may be surprised to know that mammography is the only radiologic study that's regulated by federal law, and the law requires that the equivalent of a 40 lb. car battery come down on your breast during this study. But with MBI, we use just light, pain free compression. (Applause) And the detector then transmits the image to the computer.

So here's an example. You can see on the right, a mammogram showing a faint tumor, the edges of which are blurred by the dense tissue. But the MBI image shows that tumor much more clearly, as well as a second tumor, which profoundly influence that patient's surgical options. In this example, although the mammogram found one tumor, we were able to demonstrate three discreet tumors -- one is small as three millimeters.

Our big break came in 2004. After we had demonstrated that we could find small tumors, we used these images to submit a grant to the Susan G. Komen Foundation. And we were elated when they took a chance on a team of completely unknown investigators and funded us to study 1,000 women with dense breasts, comparing a screening mammogram to an MBI. Of the tumors that we found, mammography found only 25 percent of those tumors. MBI found 83 percent. Here's an example from that screening study. The digital mammogram was read as normal and shows lots of dense tissue, but the MBI shows an area of intense uptake, which correlated with a two centimeter tumor. In this case, a one centimeter tumor. And in this case, a 45 year-old medical secretary at Mayo, who had lost her mother to breast cancer when she was very young, wanted to enroll in our study. And her mammogram showed an area of very dense tissue, but her MBI showed an area of worrisome uptake, which we can also see on a color image. And this corresponded to a tumor the size of a golf ball. But fortunately it was removed before it had spread to her lymph nodes.

So now that we knew that this technology could find three times more tumors in a dense breast, we had to solve one very important problem. We had to figure out how to lower the radiation dose. And we have spent the last three years making modifications to every aspect of the imaging system to allow this. And I'm very happy to report that we're now using a dose of radiation that is equivalent to the effective dose from one digital mammogram. And at this low dose, we're continuing this screening study, and this image from three weeks ago in a 67 year-old woman shows a normal digital mammogram, but an MBI image showing an uptake that proved to be a large cancer. So this is not just young women that it's benefiting. It's also older women with dense tissue. And we're now routinely using one-fifth the radiation dose that's used in any other type of gamma technology.

MBI generates four images per breast. MRI generates over a thousand. It takes a radiologist years of specialty training to become expert in differentiating the normal anatomic detail from the worrisome finding. But I suspect even the non-radiologists in the room can find the tumor on the MBI image. But this is why MBI is so potentially disruptive. It's as accurate as MRI, it's far less complex to interpret, and it's a fraction of the cost. But you can understand why there may be forces in the breast imaging world who prefer the status quo.

After achieving what we felt were remarkable results, our manuscript was rejected by four journals. After the fourth rejection, we requested reconsideration of the manuscript, because we strongly suspected one of the reviewers who had rejected it had a financial conflict of interest in a competing technology. Our manuscript was then accepted and will be published later this month in the journal Radiology. (Applause) We still need to complete the screening study using the low dose, and then our findings will need to be replicated at other institutions. And this could take five or more years. If this technology is widely adopted, I will not benefit financially in any way. And that is very important to me, because it allows me to continue to tell you the truth. But I recognize -- (Applause) I recognize that the adoption of this technology will depend as much on economic and political forces as it will on the soundness of the science.

The MBI unit has now been FDA approved, but it's not yet widely available. So until something is available for women with dense breasts, there are things that you should know to protect yourself. First, know your density. 90 percent of women don't, and 95 percent of women don't know that it increases your breast cancer risk. The State of Connecticut became the first and only state to mandate that women receive notification of their breast density after a mammogram. I was at a conference of 60,000 people in breast imagining last week in Chicago. And I was stunned that there was a heated debate as to whether we should be telling women what their breast density is. Of course we should. And if you don't know, please ask your doctor or read the details of your mammography report. Second, if you're pre-menopausal, try to schedule your mammogram in the first two weeks of your menstrual cycle, when breast density is relatively lower. Third, if you notice a persistent change in your breast, insist on additional imagining. And fourth and most important, the mammography debate will rage on, but I do believe that all women 40 and older should have an annual mammogram.

Mammography isn't perfect, but it's the only test that's been proven to reduce mortality from breast cancer. But this mortality banner is the very sword, which mammography's most ardent advocates use to deter innovation. Some women who develop breast cancer die from it many years later. And most women, thankfully, survive. So it takes 10 or more years for any screening method to demonstrate a reduction in mortality from breast cancer. Mammography's the only one that's been around long enough to have a chance of making that claim. It is time for us to to accept both the extraordinary successes of mammography and the limitations. We need to individualize screening based on density. For women without dense breasts, mammography is the best choice. But for women with dense breasts, we shouldn't abandon screening altogether, we need to offer them something better.

The babies that we were carrying when my patient first asked me this question are now both in middle school, and the answer has been so slow to come. She's given me her blessing to share this story with you. After undergoing biopsies that further increased her risk for cancer and losing her sister to cancer, she made the difficult decision to have a prophylactic mastectomy. We can and must do better, not just in time for her granddaughters and my daughters, but in time for you.

Thank you.

(Applause)