Accuray Receives 510(k) FDA Clearance for the RadixactTM Image-Guided Radiation Therapy Platform and Integrated Software
Next Generation "Smart" System Enables Clinicians to Provide Highly Precise Treatment, Efficiently, for More Patients, Every Day
SUNNYVALE, Calif., June 27, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RadixactTM Treatment Delivery Platform. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray PrecisionTM Treatment Planning System and iDMSTM Data Management System. These next generation hardware and software solutions which, together, make up the new Radixact system, enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment. The new Radixact system represents a major step forward in the evolution of the TomoTherapy® System in treatment speed and ease of use.
Radixact(TM) Treatment Delivery System
The system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery, so clinicians can apply highly conformal and homogenous dose distributions to any target volume, while precisely sparing normal healthy tissue during each treatment fraction. The new Accuray Precision Treatment Planning System with smart, automated workflows and midcourse decision-making tools, enables clinicians to adapt delivery to changes in tumor size, shape and location within the patient.
In the long term what is good for Liberty is good for Markets. Centralized control does not work. Especially if those in control, the regulators, have no skin in the game. Our founders fought a war, "against taxation without representation", for what the what the Brits only had to vote for. Good luck to them and and their new found freedom.
Continued ..... FUCAM Treats 1,000 Breast Cancer Patients with the TomoTherapy® System
"We are proud of the incredible work FUCAM is pioneering in Mexico and their dedication to improving the care of women with breast cancer. Their treatment milestone was achieved in a very short amount of time, demonstrating the immense need for effective breast cancer treatment in Mexico," said Joshua H. Levine, president and chief executive officer of Accuray. "The TomoTherapy System provides versatility and efficiency in the treatment of breast cancer, enabling clinicians such as Dra Huerta and her team to provide an optimal treatment for more patients."
FUCAM is a civil partnership with a mission to provide diagnosis and treatment for breast cancer, particularly in the most vulnerable socioeconomic groups, and to promote education about early detection of breast cancer. It´s the first non-profit institution established in Mexico and in Latin America with services, equipment, and highly specialized personnel fully-trained on the treatment of diseases of the breast.
FUCAM developed one of the most important campaigns in Mexico to educate women on the importance of a screening mammography in the early detection of breast cancer. For more information on FUCAM visit www.fucam.org.mx/
System Dedicated Solely to Breast Cancer Care Provides Excellent Clinical Outcomes
SUNNYVALE, Calif., June 21, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the Fundación de Cancer de Mama in México City (FUCAM) has treated 1,000 breast cancer patients with the TomoTherapy® System. The milestone was achieved less than 18 months after the center installed the technology, underscoring its value as a mainstream treatment option to maximize tumor control with low toxicities for the full range of breast cancer cases, from routine to complex.
"FUCAM is a large and busy center focused on providing the best possible care to women with breast cancer. We require a radiation therapy system which can keep pace with the demands of our clinic and enable us to deliver precise radiation to any tumor in the shortest amount of time possible," said Dra Judith Huerta Bahena, head of radiotherapy, Institute of Diseases of the Breast, FUCAM. "The TomoTherapy System helps us do just that with its TomoHelicalTM and TomoDirectTM treatment modes. The System provides the flexibility we need to precisely conform the radiation dose to the shape of the tumor and significantly decrease dose to nearby healthy organs and tissues."
The TomoTherapy System is the only radiation system specifically designed for image-guided intensity-modulated radiation therapy (IG-IMRT). Leveraging a CT scanner-based platform, TomoHelicalTM mode enables continuous delivery from 360 degrees around the patient with highly conformal and homogeneous dose to the tumor. A clinician can also choose to deliver treatment from specific fixed angles via TomoDirectTM mode. The system's unique architecture helps ensure the highest levels of precision, while minimizing dose to organs at risk. This is especially important for women diagnosed with cancer in the left breast, where the tumor may be close to critical organs such as the heart.
United Kingdom's NHS Supply Chain to Acquire Seven TomoTherapy® Systems
Largest Ever Accuray Deal Will Provide More Cancer Patients in the United Kingdom (UK) Access to Advanced, Precise Radiation Treatments
Because getting RXI recognized in the June 2016 issue of Drug Discovery News, a widely distributed publication, is new news.
MR guidance could also enable radiation treatment of non-oncologic diseases such as atrial fibrillation, currently treated via an invasive, expensive procedure. By using MRI to image the beating heart and define the small, moving target volumes, it's possible to noninvasively treat one of the most common conditions. And if physicians start to use radiation for this application, more radiotherapy departments will be needed.
Finally, Keall described the use of online MRI guidance to enable physiological targeting during radiotherapy, which no other technology can achieve. "Cancer physiology is heterogeneous and changes with time," he said, citing tumour hypoxia, which can change during a single treatment. "The ability to selectively image and target the most resistant parts of cancer could dramatically change cancer outcomes."
Are we already good enough?
Retaking the stage, Lohr addressed some of Keall's arguments. Yes, MR guidance is obvious, he agreed, but only if you've got the money. With MR-guided systems costing three times that of other radiotherapy devices, the question is "how much good can we achieve with more imaging". Lohr also noted that many professionals still do not concur that daily online imaging is useful.
Direct imaging of the tumour is already possible, said Lohr, if you treat in a static breath-hold situation, which can be created today. He noted that using MRI to enable radiation treatments of atrial fibrillation is indeed promising and merits evaluation.
As for functional imaging, Lohr again questioned whether currently available field strengths are sufficient and wondered which processes change within minutes and thus necessitate online imaging. Functional information could instead be gathered offline, he suggested, and integrated into treatment plans. "We shouldn't feel too bad, because we're already pretty good at what we're doing," he concluded.
Keall emphasized that patient motion is complex, with translations, rotations, deformations and changes in physical properties to account for. "Our patients are dynamic, our anatomy is dynamic and our physiology is dynamic," he said. And it's not just target motion that needs tracking. If a tumour is located next to the heart, for example, MRI can visualize the beating heart to reduce treatment toxicity. And while ultrasound imaging may be cheaper, image quality is far superior with MRI and of particular benefit in sites such as the kidney and liver.
Looking at the introduction of other advanced radiotherapy technologies, a show-of-hands revealed that almost all of the audience now perform stereotactic body radiotherapy, whereas 10 years ago only about 20% were using this approach. Likewise, almost everyone now employs some form of image guidance, while less than 10% were doing this 10 years previous. "I think that what we're doing with MRI is the same," said Keall.
He listed the many companies and institutions now building MR-guided radiotherapy devices. This includes ViewRay, with 20 confirmed sales to date and Elekta, which plans to ship 79 units by 2019 – a combined market of $1bn. Last year, the University of Alberta group founded Magnet-Tx to commercialize its Aurora RT, while both Siemens and the Australian MR-linac programme demonstrated prototypes.
MR-guided radiotherapy systems
Other reasons for implementing online MR guidance include the ability to exploit existing MRI expertise, the lack of imaging dose and the ability to image actual anatomy as opposed to surrogates.
If you listen to Accurays May 20, 2016 3 hours webcast the doctor mentioned that Indiana University had a Protron Installation that they cannot give away. Google
" As a proton therapy center closes, some see it as a sign "
An excerpt from that article follows:
[ By Jaimy Lee | September 18, 2014
The Indiana University Proton Therapy Center will close in December, marking the first time a proton-beam therapy center in the U.S. has shut its doors since the rapid proliferation of the costly treatment centers began about a decade ago.
University executives and an independent review committee attributed the center's financial losses to a range of issues, including the cost of maintaining its aging cyclotron, but the committee also suggested the industry may be on the verge of a “proton bubble” as the centers struggle to serve a sufficiently large patient population.
Many of the centers have based their volume expectations on treating prostate cancer patients, but insurers have increasingly started to push back against providing coverage of proton therapy for these patients because of a lack of evidence proving superior benefits over other treatments.
Blue Shield of California and Aetna last year said they would no longer cover proton therapy as a treatment for localized prostate cancer. Cigna Corp. does not cover proton-beam therapy in the treatment of prostate cancer either.
“I look at this closure as a sign that insurers are finally empowered to say this is a dubious medical technology” in the treatment of patients with prostate cancer, said Amitabh Chandra, director of health policy research at the Harvard Kennedy School of Government. “The 'build it and they will come' philosophy around these centers is being questioned.” ]
[ "We are honored to be a part of a very important project that will help to make the most advanced proton therapy available to the people of Russia," said Moataz Karmalawy, general manager of Varian's Particle Therapy division. "The ProBeam system combines Varian's unmatched technology for intensity modulated proton therapy with advanced imaging, treatment planning, and information management capabilities that have been developed on the basis of decades of experience in radiation oncology. This cyclotron installation is another exciting step forward for proton therapy."
Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects is reduced because the beam is designed to stop and deposit dose within the tumor site rather than passing all the way through the patient. Proton therapy can be used for many of the most common types of cancer.
Varian's ProBeam technology is being used to treat patients at the Scripps Proton Therapy Center in San Diego, the Maryland Proton Therapy Center in Baltimore, the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland. Varian also has contracts for system installations at ten other sites around the world. Varian's ProBeam system with Dynamic Peak™ Scanning is uniquely capable of high-speed intensity modulated proton therapy (IMPT), which is the most precise form of proton therapy available. ]
Varian is in stalling a proton system is Russia. It takes 2 cranes to install. Following from Varian press release
[ VARIAN AND RUSSIAN PROTON THERAPY CENTER ACHIEVE MILESTONE WITH CYCLOTRON INSTALLATION
Jun 9, 2016
ST. PETERSBURG, Russia, June 9, 2016 /PRNewswire/ -- Russia's first dedicated proton therapy treatment center achieved a major milestone this week with the installation of the cyclotron by equipment supplier Varian Medical Systems (NYSE: VAR). The installation, a key milestone for each new proton therapy center, involved the cyclotron being lifted into position by cranes in a procedure that was watched by local government officials including the governor of St. Petersburg.
The cyclotron being lifted by cranes for installation at St. Petersburg.
The cyclotron, a particle accelerator which accelerates protons to two thirds of the speed of light for clinical use, is a core piece of equipment of Varian's ProBeam® system, which is equipping the two-room PTC St. Petersburg Center of Nuclear Medicine of the International Institute of Biological Systems. Patient treatments are expected to start at the new facility late next year. Clinicians at the center expect to treat around 1,000 patients each year.
"We're very pleased to be able to bring Varian's cutting edge, clinically advanced and reliable technology to patients and the cyclotron installation is the first major milestone in equipping the center," said Dr. Arkadi Stolpner, chairman of the International Institute of Biological Systems Diagnostic and Treatment Center. "Around half a million new cases of cancer are diagnosed annually in the Russian Federation and our aim in installing the Varian ProBeam system is to help us meet our mission of saving lives." ]
Finally, I went to the trouble of copying this here because it answers a lot of questions about whether Accuray is headed in the right direction and missing out on MRI guided radiotherapy. In my opinion MRI guided radotherapy in not needed. This was also a takeaway from the May 20, 2016 3 hour webcast by thee 3 doctors. I seems Accuray is well positioned and technologically headed in the right direction.
Finally, Keall countered some of Lohr's concerns. In terms of whether improved geometric accuracy leads to a better outcome, he emphasized that motion is the biggest error in the radiotherapy dosimetry chain. As for the inability of current MRI-guided radiotherapy systems to use non-coplanar beams, Keall explained that coplanar beams most common in today's treatments. "If it turns out that multiple coplanar beams are used more in the future, we can work to integrate MR machines to do this," he said.
As for the system cost, Keall noted that when integrated PET/CT systems were first introduced, people questioned the need to merge two expensive machines. But the benefit of integration was strong enough to justify itself, and all PET systems are now integrated with CT. "It is cost-effective to add image-guidance to reduce toxicity," concluded Keall.
• Is MR guidance feasible for protons?
• Where next for MRI-guided radiotherapy?
• Four takes on intra-fraction motion monitoring
• Algorithm enables boost in CBCT quality
About the author
Tami Freeman is editor of medicalphysicsweb.org
Finally, Lohr considered MRI's unique ability to image physiological variations. The ability to identify functionally active lung tissue and optimize radiation delivery to avoid these areas, for example, could prove of massive benefit. "But how much of this information is needed on a minute-by-minute basis?" he asked. "Could this be performed offline?" He noted that online MR-based functional imaging is limited by currently available field strengths. Should this change, however, and targets identified that require high-resolution dose deposition and daily changes in targeting strategy, this could represent the ultimate application of online MRI guidance.
Lohr reiterated the precision treatment delivery afforded by today's IGRT approaches. "If we really need online MR guidance, shouldn't we do everything we can with what we already have to get as near as possible?" he concluded.
Making the case for MRI
"The organizers gave me the easiest job in the world…" declared the University of Sydney's Paul Keall, "to convince you that the future of radiotherapy involves integrated MR-guided machines." Keall went on to list 10 reasons why the unparalleled soft-tissue contrast afforded by MRI is essential.
Paul Keall from the University of Sydney
"It's obvious," he said. "We need to see the tumour anatomy throughout treatment." He asked the audience to close their eyes and then shake hands with the person next to them. "This is what we're doing now in radiotherapy."
continued - 1
Addressing breathing motion during radiotherapy
As for where the improved geometric accuracy may create a better outcome, Lohr says that it could benefit large lung and liver tumours, and possibly targets in the kidney and pancreas. For small lung and liver targets, it is unlikely that better geometric accuracy will further improve results. He also noted that current MRI-guided radiotherapy systems cannot deliver non-coplanar beams.
"We already have tools that get us to near perfect accuracy," said Lohr, citing the Gamma Knife and CyberKnife radiosurgery systems, and motion tracking systems such as ExacTrac and Calypso. "And brachytherapy already uses MRI guidance."
So what level of accuracy can be achieved with guidance approaches available on conventional linacs today? Cone-beam CT (CBCT) with deep inspiration breath hold (DIBH) can achieve an accuracy of 2–3 mm, says Lohr, noting that DIBH used to be cumbersome and slow, but is now faster and easier to perform. This approach was facilitated by the development of flattening filter-free delivery and fast collimators that shorten the treatment duration, as well as positioning devices such as surface scanners and fiducial tracking. In addition, recent work in applied physiology has indicated that breath holds of several minutes can be sustained with minimal preparation.
DIBH with ultrafast kVMV CBCT guidance
Another technology that may return to mainstream use is ultrasound, which offers excellent soft-tissue image quality where applicable and benefits from improved tracking algorithms.
MR-guided radiotherapy: how great is the need?
Online MRI-guided radiotherapy enables real-time, high-precision visualization of anatomical changes during treatment delivery. But with many image-guided radiotherapy (IGRT) options available already, how great is the need for large-scale in-room MR guidance? This was the question under debate at the recent ESTRO 35 conference in Turin, Italy.
"Do we want a system that allows us to see what we are treating in real time? Yes absolutely," said Frank Lohr, previously at University Medical Center Mannheim, now at the Azienda Ospedaliero-Universitaria Modena. "But the economics have to be justified." Lohr questioned whether online MRI guidance will really make a qualitative difference, or whether we should instead focus on exploiting the advanced image-guidance strategies that are already available. He indicated that online MRI guidance might have implications in two areas: geometrical treatment accuracy and biologically/functionally driven strategies.
Lohr first considered the current accuracy status in radiotherapy. The main problem is breathing motion, which can create uncertainties in dose delivery and target coverage. Margins are applied to account for such motion, but at the expense of normal tissue irradiation; while approaches such as breath hold, gating and tracking enable margin reduction.
I cannot either, however, I think it is worry about Brexit how that might affect the Euro and strenght of dollar versus other currencies. Day-to-day markets can be very myoptic and fickle.
Joint Trial Analysis Confirms Benefit of Anthracyclines in High-Risk Breast Cancer
"According to data presented at the 2016 ASCO Annual Meeting, docetaxel plus cyclophosphamide (TC) was significantly inferior to various taxane-plus-anthracycline-based (TaxAC) chemotherapy regimens."
Doxorubicin, an Anthracyclines, a is one of the most widely used chemotherapeutic agents and is generally prescribed in combination with other drugs. ... It is one of the most effective drugs for solid tumor treatment, e.g., breast cancer, small cell lung cancer and ovarian carcinoma treatments.
So though the above study did not involve Aldoxorubicin, it bodes well for Aldoxorubicin.