The MRIdian Advantage

Transcription

1 The MRIdian Advantage

2 SIMULTANEOUS IMAGING AND TREATMENT because organ motion matters Visibly Different It is a simple truth. Involuntary life-sustaining movements don t stop while your patients are receiving radiation therapy. As your patient moves the tumor moves too! At ViewRay we understand that the best way to deliver an accurate dose of radiation to a moving target is to be able to see inside the body at the time of treatment. That is why we designed the world s first and only MRI-Guided Radiation Therapy System that can image and treat cancer patients simultaneously. MRIdian is the next-generation radiotherapy solution that integrates MRI technology, radiation delivery and our proprietary software to locate, target and track the position and shape of tumors while radiation is delivered. MRIdian is the only system in the world that can provide continuous soft-tissue imaging during radiation treatment. Being able to constantly see both the tumor and surrounding organs means you can accurately align the tumor to the treatment beams and make adjustments in real time to avoid sensitive internal structures. MRIdian s proprietary Monte Carlo algorithm and software, allows you to review and adapt the treatment plan while the patient is on the table. Our MRI-based technology improves tumor visibility and spares as much healthy tissue as possible while powerful tracking tools make sure only the precise amount of radiation prescribed is delivered. The treatment sequences are recorded so you can evaluate the therapy session at any time or share it with your patient for added peace of mind. During the next year, the National Cancer Institute estimates that there will be over a million newlydiagnosed cancer cases in America. Of these, nearly two-thirds will receive some form of radiation therapy during the course of their illness, according to the American Society for Radiation Oncology (ASTRO). With MRIdian s enhanced visualization and motion management tools you can treat your patients with clinical confidence, knowing that you will be able to target the tumor accurately and deliver less radiation to your patients healthy tissue. Image and treat simultaneously with MRIdian because organ motion matters!

3 ALIGN ADAPT AND TRACK MRIdian is the world s first and only MRI-guided radiation therapy system that can image and treat cancer patients simultaneously. MRIdian Improves tumor visibility and patient alignment Tracks tumors and manages patient motion Provides on-table adaptive RT planning Accurately records delivered radiation dose Supports advanced therapy techniques Fits into existing treatment paradigms and workflow MRIdian marries real-time MRI scanning with the delivery of radiation and this is a very important new development in the field of radiation oncology. As patients are breathing, and tumors are moving during treatment, we can more precisely guide the radiation to their tumor. When we treat patients with MRIdian we are able to diminish the amount of normal tissue that gets exposed. Paul M. Harari, M.D. Radiation Oncologist University of Wisconsin Carbone Cancer Center We know that tumors and normal tissue move around all the time. We need to adjust to that and MRIdian finally allows us to do that in real time. We truly believe this is going to impact and improve the outcomes of patients getting radiation therapy. Percy Lee, M.D. Radiation Oncologist UCLA Health System and Jonsson Comprehensive Cancer Center They can see everything that s going on in my pelvic area and it s very comforting to know that they re getting right on the spot where they re supposed to get. Margaret Vandebree Cancer Patient Treated on MRIdian

4 MRIdian TREATMENTS BREAST HEART LIVER PANCREAS COLON BLADDER PROSTATE RECTUM HEAD AND NECK BRAIN BONE LUNG STOMACH ESOPHAGUS FLANK MESENTERY ADRENAL GLANDS SUPERCLAV KIDNEY OVARY UTERUS ABDOMINAL WALL PERIAORTIC LYMPH NODES

5 ACCURATE TARGETING with MRI-based technology FDA-cleared since 2012, MRIdian is actively being used to treat cancer patients at leading cancer centers around the world including Washington University and Siteman Cancer Center at Barnes-Jewish Hospital University of California Los Angeles Health System and Jonsson Comprehensive Cancer Center The University of Wisconsin Carbone Cancer Center Seoul National University Hospital in Seoul, South Korea Washington University Clinical Dashboard Abdominal Wall Adrenal Gland Bladder Bone Brain Breast Colon Esophagus Flank Head and Neck Heart Liver Lung Mediastinal LNs Mesenteric Neck LN Pancreas Periaortic LN Prostate Rectum Stomach Superclav MRIdian is currently being used to treat many different types of cancer in radiation therapy patients across a full spectrum of disease sites. We believe it will soon become the preferred method of treatment for complex cancer cases that are difficult to treat on a standard LINAC due to the location of the tumor in relation to the surrounding soft tissue. The most significant advantage of MRIdian is that it offers integrated magnetic resonance imaging capabilities. This addresses a key limitation of existing external-beam radiation therapy solutions because it uses MRI-based technology to provide real-time imaging during radiation treatment. MRI is the clinically preferred method of imaging soft tissue because it provides high-contrast images without exposing the patient to unnecessary ionizing radiation. Essentially, MRI improves tumor visibility by clearly defining the targeted tumor from the surrounding soft tissue and other critical organs. MRIdian allows for accurate tumor alignment to the treatment beams without the use of X-ray, CT or invasive surrogate markers. MRIdian s increased target accuracy allows you to treat patients with higher doses of radiation over fewer treatment fractions. This, combined with improved tumor visibility and accurate dose recordings, means you can treat patients who would not previously have been considered radiation therapy candidates. MRIdian helps you achieve the goal of curative radiation therapy by balancing the delivery of a sufficiently high dose of radiation to a tumor to kill cancer cells while, at the same time, minimizing damage to healthy cells, particularly those in critical organs. We believe this improves the safety and efficacy of radiation therapy and leads to improved patient outcomes with reduced side effects from offtarget radiation delivery.

6 ULTRA-FAST TREATMENT PLANNING without compromising quality MRIdian offers an adaptive, automated and integrated treatment planning system that uses cobalt-60 sources to deliver modulated radiation therapy. Our proprietary Monte Carlo Treatment Planning System is ultra-fast without compromising quality. MRIdian fits into existing treatment paradigms and can be used for three-dimensional conformal radiation therapy planning (3D-CRT); intensity modulated radiation therapy planning (IMRT); stereotactic radiosurgery (SRS); stereotactic body radiation therapy (SBRT); and image-guided radiation therapy (IGRT); across a broad spectrum of disease sites. Treatment Planning Workstations (TPW) Both Treatment Planning and Delivery workstations have a minimum of twelve processor cores, 64GB RAM, 1.5GB video memory, ample hard disk space and an oversized LCD display. Treatment Planning and Delivery Software (TPDS) The TPDS operates on both a remote TPW and on the treatment delivery system. Treatment plans may be created to pre-plan treatment using volumetric CT, MRI, or PET images on remote workstations. The TPDS is designed to create optimized 3D-CRT, IMRT, SRS and SBRT, conformal and combinations of IMRT and conformal treatment plans for delivery on our IGRT system. In a recent article Benchmark IMRT Evaluation of a Co-60 MRI-guided Radiation Therapy System published in the journal of the European Society for Radiotherapy and Oncology, a team of top physicists from the Washington University School of Medicine evaluated an MRI-guided radiation therapy (MR-IGRT) device that uses cobalt-60 sources to deliver intensity modulated radiation therapy. In particular, they investigated the performance of the treatment planning and delivery system against the benchmark recommended by the American Association of Physicists in Medicine (AAPM) Task Group 119 for IMRT commissioning and demonstrated that the device plans and delivers IMRT treatments within recommended confidence limits and with similar accuracy as LINAC IMRT. H. Omar Wooten et al Department of Radiation Oncology Washington University School of Medicine St. Louis, Missouri

7 APBI LEFT BREAST Female: 56 years old with T1bN0 Grade 1 adenocarcinoma and history of stage IV adenosarcoma of the uterus. Treated with accelerated partial breast irradiation (APBI) using LINAC based 3DCRT created with Pinnacle. RX: 0.5Gy in 10 fractions, 3.85Gy/Fx, over 2 weeks MRIdian LINAC Structure Prescription Goals Linac Plan MRIdian Plan PTV 38.5Gy >90% at 38.5Gy 85.0% 89.2% L Breast <60% at 19.3Gy 56.0% 51.8% L Breast <35% at 38.5Gy 22.4% 19.0% L Lung <15% at 11.6Gy 13.8% 8.0% R Lung <15% at 1.93Gy 30.4% 27.5% Heart <40% at 1.93Gy 37.2% 30.8% CONCLUSION Breast position and shape can differ daily and can be difficult to set up consistently; while heart dose is a limiting factor in left breast treatments. With MRIdian, you can deliver a highly conformal dose to the target with minimized dose to the healthy breast tissue and sensitive structures. Simultaneous imaging during treatment gives you the confidence to know that the target is being treated as planned and the heart dose can be monitored and maintained. PANCREAS Female: 68 years old with locally advanced stage II pancreatic cancer. Adenocarcinoma. Comprehensive treatment plan included chemotherapy with concurrent radiation therapy. Rx: 50.4Gy in 28 Fractions; 1.80Gy Daily MRIdian Treatment Plan Structure Prescription Goals MRIdian Plan * better than or equal to PTV 50.4 >90% at 50.4Gy 95% * R Kidney Mean < 18Gy 1.2 Gy * Duodenum <10% at 50Gy 1.8% * Duodenum Max <54Gy 52.6 Gy * Small Bowel <10% at 50Gy 0 Gy * PTV Duodenum Stomach SM Bowel Kidney_R Small Bowel Max <54Gy 42.0% * CONCLUSION Most pancreatic cancers are difficult to resect due to the organ s proximal location to the celiac and superior mesenteric arteries along with the portal vein in the abdominal cavity. The head of the pancreas is located within the curve of the duodenum. It is important to track the portal vein or pancreatic head during treatment because the duodenum is very sensitive to radiation. MRIdian allows you to continuously monitor the target area with a gated breathing technique. Simultaneous imaging during treatment means you can be confident that the target is being treated as planned.

8 MRIdian Treatment Flow MRI Positioning Scan ALIGN DAILY TREATMENT FLOW under 20 minutes MRI Positioning Scan Patient Setup An integrated MRI unit captures volumetric soft-tissue images for accurate pretreatment positioning in just a few seconds. The highquality soft-tissue contrast allows you to locate the tumor and align the patient to the treatment beams accurately without using X-ray, CT or surrogate registration markers. MRIdian allows for accurate automatic patient alignment. Auto-Contour ADAPT Auto-Contour MRIdian provides real-time imaging that clearly defines the targeted tumor from the surrounding soft tissue and other critical organs. Using an MRI image captured at the beginning of each therapy session, the system automatically identifies and maps the patient s soft tissue anatomy in 3D. It then transfers contours to the daily image using a rigid or deformable registration. On-Table Dose Prediction On-Table Dose Prediction On-table dose computation rapidly produces dose distributions and DVH s to predict the anticipated dose delivery. While the patient is on the treatment table the system compares the pretreatment MRI image to the planning image and automatically calculates the required dose to be delivered to the target using the current treatment plan. If the dose prediction and prescribed treatment is not clinically acceptable, you can change this on demand. On-Demand Optimization On-Demand Optimization Utilizing our proprietary Monte Carlo algorithm and software, MRIdian calculates the optimal treatment plan for the patient at the time of treatment. MRIdian has the ability to automatically recalculate the dose and adapt the treatment plan to changes in the patient s anatomy at the time of treatment. You can re-optimize and re-plan your treatment session in under two minutes while the patient is on the table.

9 Track Tissue and Verify Target TRACK Track Tissue and Manage Patient Motion MRIdian captures multiple soft-tissue imaging planes concurrently during treatment, refreshing the image multiple times per second. This real-time imaging allows you to track the movement of the tumor and the surrounding healthy tissue directly as well as verify the target and tracking boundary. If a tumor or critical organ moves beyond a physician-defined boundary, the treatment beam automatically pauses. When the tumor moves back into the predefined boundary, treatment automatically resumes. Beam control is especially important in situations where tumors may be in close proximity to critical organs. Treatment: Lung Cancer Treatment MRIdian can be used for 3D-CRT, IMRT, IGRT, SBRT and SRS across a broad spectrum of disease sites. MRIdian s increased target accuracy allows you to treat patients with higher doses of radiation over fewer treatment fractions. This, combined with improved tumor visibility and accurate dose recordings, means you can treat patients who would not previously have been considered radiation therapy candidates. MRIdian also captures and records a video called MRIdian Movie of the delivered treatments for later evaluation or for sharing with your patients. Physician Workstation Physician Review MRIdian calculates the dose delivered after each treatment and records the level of radiation exposure that the tumor has received, allowing you to review and adapt the prescription between fractions on demand. MRIdian provides you with complete information and a wide range of powerful review and assessment tools, allowing you to deliver targeted, personalized radiotherapy for each patient. TREATMENT FLOW Minute Time Slot ALIGN ADAPT AND TRACK WITH VISUAL CLINICAL CONFIDENCE Patient Setup Auto-Contour Dose Prediction Re-Optimization Track & Verify Treatment MD Review

10 CLINICAL FILES patient case studies ESOPHAGUS Adenocarcinoma of Distal Esophagus Mr. B. was treated for adenocarcinoma of the distal esophagus, with EUS demonstrating malignant appearing lymph nodes in the lower paraesophageal, paracardial, and celiac region. RX: 2.0Gy in 25 fractions; 50.0Gy total BREAST RECURRENCE Mediastinum Metastatic Adenocarcinoma Mrs. M. received prior treatment to her right breast with a conventional arrangement that included tangents and a superclav field (SCV). A recurrence in the perioartic arch node was close to the original target and required careful treatment planning. Her M.D. chose MRIdian to treat his patient because he was able to confidently treat the area with a minimal margin applied to the target. RX: 2.0Gy in 33 fractions; 66.0Gy total The image above left shows the GTV delineated by the physician from the CT simulation. The image above right from the MRIdian simulation shows the updated GTV. A large area of this target was not visible on the CT and therefore could have been missed without the MRI. COLON Sigmoid Colon Cancer with Bladder Invasion Mr. W. received treatment due to a large sigmoid tumor that was invading his bladder. Dr. K. chose MRIdian because of the enhanced visualization capabilities of the system, which allowed him to locate and accurately track the motion of this bulky tumor as well as easily adapt the treatment plan to anatomy changes on table. He was very pleased with the imaging results as he was easily able to monitor the changes in the gross tumor. Images L to R are taken from the first and second week of treatment with the original PTV displayed and show the changes in tumor size. RX: 2.3Gy in 24 fractions; 55.2Gy total

11 MESENTERY Intra-abdominal Mesenteric Desmoid Tumor Ms. N. received treatment for a mesenteric desmoid tumor that did not respond to systemic therapy and was un-resectable. Several plans were made for this tumor due to its ability to move drastically both longitudinally and laterally. Ultimately her physician chose MRIdian to treat her because of the system s ability to accurately align and track motion. Image Top Left is the CT simulation with the PTV displayed. MRIdian images below taken during first fraction of treatment show the extreme displacement of the tumor. RX: 1.8Gy in 30 fractions; 54.0Gy total BLADDER Urinary Bladder Urothelial Cell Carcinoma Dr. H. chose MRIdian to treat Mr. V. s bladder boost. Mr. V. was instructed to have an empty bladder for his treatments. The images right illustrate the bladder filling from day to day. MRIdian gives clinicians the ability to adapt to targets as well as critical structures on a daily basis. RX Original: 1.8Gy in 22 fractions; 39.6Gy total RX Boost: 1.8Gy in 14 fractions; 25.2Gy total

12 MRIdian supports advanced therapy techniques and fits into existing treatment paradigms. It is fully application-oriented and integrates An interventional MRI-imaging system An autonomous radiation therapy system Intelligent automated software

13 FULLY INTEGRATED SYSTEM for intuitive workflow INTERVENTIONAL MRI-IMAGING SYSTEM Split Superconducting Magnet Fits in standard vaults with pop-apart design for non-destructive rigging. Field strength of 0.35 Tesla provides 50cm diameter of spherical volume (DSV) for large field of view (FOV) imaging. Allows unobstructed beam path. Designed for simultaneous soft-tissue imaging during therapy. Low-field MRI does not distort patient images or dose distributions and does not heat patients. State-of-the-art split gradient coil with massive cooling capacity for unlimited fast scanning. Patient bore diameter of 70cm accommodates large patients. Low-density uniformly radiation-attenuating receive coils ensure superior image quality and optimal dose distributions. AUTONOMOUS RADIATION THERAPY SYSTEM Rotating Gantry Assembly Enable fast IMRT, SBRT or conformal external beam radiation with asynchronous delivery. Mounted with 120-degree separation. High activity cobalt-60 sources. INTELLIGENT AUTOMATED SOFTWARE Comprehensive Database and Informatics System Captures all simulation, treatment planning and the treatment delivery information including automatic archiving of all parameters, images, treatment plans and accumulated dose to target via deformable image registration and Monte Carlo simulation. On-table Adaptive Treatment Planning Whole plan auto-contouring, real-time Monte Carlo and full-scale IMRT and SBRT optimization in under 2 minutes. Tracking of Soft Tissue to Control Delivery On-the-fly target registration and real-time beam control. INTEGRATED WORKFLOW Operator s Console An integrated console to control and monitor MRI imaging, patient positioning, real-time tissue tracking and treatment. A range of tools to allow on-table dose prediction and treatment plan re-optimization enabling truly adaptive treatments. Treatment Planning Station For multi-modality image review and manipulation. To define structures and constraints. To plan and optimize treatments. Full review capabilities to monitor treatment progress. Automatically Updated Database Server Captures all patient and machine data. Three Independent Cobalt-60 Therapy Heads The 240 degree rotation for 2 or 3 head operation promotes maximum reliability. Three Doubly-Focused Multlileaf Collimators (MLC) System features 180 MLC leaves, 60 per head. Best-in-class MLC for reduced penumbra and interleaf leakage.

14 SOPHISTICATED SCIENTIFIC DESIGN optimal field strength for radiation therapy Visibly Different MRI SYSTEM One of the most significant advantages of MRIdian is that it integrates an MRI system with a Radiation Delivery System. The MRI component of MRIdian captures soft tissue images of the patient s body simultaneously during treatment. We have engineered our MRI system to be able to produce high-quality images using a low field strength 0.35 Tesla magnet. One of the key benefits of this design is that it provides optimal field strength for radiation therapy. The 0.35 Tesla magnet allows the system to avoid the spatial deformity and dose distortions that occur when using a high field strength magnet. MRIdian s low field MRI allows for geometrically precise images and accurate dose distributions. Furthermore, MRIdian s 0.35 Tesla field strength does not heat the patient during uninterrupted imaging. Another feature of our patented design is the split superconducting magnet. This addresses technical complications that can arise from combining an MRI with a LINAC because the split magnet allows for unobstructed beam path through a central gap. 1. Split Superconducting Magnet 2. Gantry 3. Patient Handling System 4. Source Heads 5. Split Gradient Coil

15 RADIATION DELIVERY SYSTEM Radiation is delivered from three independent cobalt- 60 radiation therapy heads symmetrically mounted on a rotating ring gantry. This promotes maximum reliability and is significantly different from prior cobalt-60 systems that have historically been limited by imprecise radiation dose applications. The sophisticated design of our system provides full 360-degree coverage and simultaneous dose delivery. Furthermore, each head is equipped with a double-focused multi-leaf collimator, which has been designed to overcome the large penumbra of previous-generation cobalt-60 systems and to shape the beam for precision radiation therapy treatments. We also use cobalt-60 because it does not create any radio frequency that may interfere with the MRI. MRIdian enables fast-delivery of treatment plans for 3D-CRT, IMRT and SBRT that are clinically equivalent to those produced on the most advanced linear accelerators available today. Our patented technology allows you to perform stereotactic procedures with a positioning accuracy of less than one millimeter. "Tumors often move throughout the breathing cycle, and MRI guidance provides a novel way to manage respiratory motion. The MRIdian technology allows for visual confirmation of accurate tumor position during radiotherapy and potentially decreases the dose of radiation to normal organs at risk during treatment." Michael Bassetti, M.D. Radiation Oncologist University of Wisconsin Carbone Cancer Center It is incredible what this instrument can do in terms of delivering precise radiation therapy to the tumor. Carlos A. Perez, M.D. Department of Radiation Oncology Washington University School of Medicine St. Louis, Missouri We can see things that we just haven t seen before. Sasa Mutic, Ph.D. Department of Radiation Oncology Washington University School of Medicine St. Louis, Missouri Clearly the game-changer is real-time imaging and MRI soft tissue contrast. Dan Low, Ph.D. Radiation Oncologist UCLA Health System and Jonsson Comprehensive Cancer Center

16 SITEMAN CANCER CENTER AT BARNES-JEWISH HOSPITAL AND WASHINGTON UNIVERSITY St. Louis, Missouri UNIVERSITY OF WISCONSIN CARBONE CANCER CENTER Madison, Wisconsin UCLA HEALTH SYSTEM JONSSON COMPREHENSIVE CANCER CENTER Los Angeles, California

17 SPACE REQUIREMENTS EASY SITE PLANNING system fits into a standard vault Recommended Vault Size: 19-2 (5.9 m) x 24-8 (7.6 m) Minimum Finished Ceiling Height: 9-6 (2.9 m) Minimum Clear Opening into Vault: 3-11 (1.2 m) W x 6-11 H (2.1 m) Recommended RF Closet Size: 3-8 (1.1 m) x 4-0 (1.2 m) MRIdian is designed to fit into a typical radiation therapy vault, similar to other replacement linear accelerators. All of the components fit through standard hospital vault entrances for easy assembly. SEOUL NATIONAL UNIVERSITY HOSPITAL Seoul, South Korea

18 ViewRay, Inc. (OTCQB:VRAY) is a medical device company developing advanced radiation therapy technology for the treatment of cancer. ViewRay holds the exclusive worldwide license for its combination of MRI and radiation therapy technologies. MRI-guided radiation therapy was conceived by company founder James F. Dempsey, Ph.D., while he was a member of the radiation oncology faculty at the University of Florida in ViewRay designs, manufactures and markets MRIdian the world s first and only MRI-guided radiation therapy system that can image and treat cancer patients simultaneously.

19 VIEWRAY exclusively focused on MRI-guided radiation therapy As innovators of MRI-guided radiation therapy ViewRay continues to add to a growing list of industry firsts First on-table adaptive RT system First patient treated with MRI-guided RT First FDA-cleared MRI-guided RT system First CE-marked MRI-guided RT system First to provide direct soft tissue tracking First exclusively Monte Carlo TPS First MRI-guided system to fit in standard vaults At ViewRay we believe that MRI-guided radiation delivery should be the standard of care for radiation therapy. We are partnering with top-tier hospitals including leading university research and teaching hospitals in a global effort to educate radiation oncologists about the capabilities and resulting benefits of MRIdian over traditional radiation therapy systems. We intend to maintain our competitive lead in MRIguided radiation therapy and adaptive treatment planning by committing to continued innovation. We are working with leading cancer centers and early adopters of best-in-class technology to collect and publish data on clinical efficacy, treatment times and clinical results for patients who have been treated on MRIdian. We plan to continue to support the publication of clinical and scientific data and analysis, work with key opinion leaders, present at leading academic conferences and engage in outreach at leading hospitals worldwide. Utilizing professional feedback to guide product development, we plan to continue to introduce enhancements to the system that will maximize the efficiency and effectiveness of MRIdian for our customers and improve patient outcomes. ViewRay is exclusively focused on MRI-guided radiation therapy. By continuing to invest in our technology we are confident that we will maintain our leadership position in the emerging MRI-guided radiation therapy market.

20 ViewRay Corporate Headquarters 2 Thermo Fisher Way Oakwood Village, OH USA Tel: ViewRay West Coast Office 815 East Middlefield Road Mountain View, CA USA ill L-0013 Rev. D 10/2015look like this: