IGRT/Adaptive Gating

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Theresa Beasley
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1 IGRT/Adaptive Gating

unlocking possibilities exceeding limits with confidence PIONEERING IGRT BrainLAB is committed to providing the best radiotherapy solutions for better treatment and patient care.

2 unlocking possibilities exceeding limits with confidence PIONEERING IGRT BrainLAB is committed to providing the best radiotherapy solutions for better treatment and patient care. BrainLAB has over a decade of experience in image-guided radiation therapy (IGRT). Today, as the leading provider of stereotactic treatment and IGRT solutions, BrainLAB continues to pioneer in higher precision and efficiency for a rapidly growing range of indications for the cranium, spine, lung and liver. BrainLAB extends its lead with ExacTrac X-Ray 6D, an automated patient positioning system that pinpoints internal tumors, corrects patient set-up and tracks patient movement throughout treatment. Adding ExacTrac transforms an existing Linac into a millimeterprecise IGRT solution for a wide range of indications. Constant innovation and a strong background in imaging, tracking and userfriendly software will continue to make BrainLAB the first to overcome treatment challenges in the future.

3 4 3 2 Lateral (mm) Longitudinal (mm) Scatter diagram of lateral-longitudinal positioning accuracy of multiple fractions based on phantom measurements after set-up using the ExacTrac X-Ray 6D positioning system: the 95% confidence level of the measured data is shown in green 1 CLINICAL CONFIDENCE With ExacTrac X-Ray 6D, BrainLAB has answered the most critical question in radiotherapy: How to precisely deliver a high treatment dose to a defined volume with confidence. In 2000, BrainLAB pioneered the first clinically implemented x-ray positioning system. Today, over 65 leading hospitals around the world rely upon BrainLAB image-guided patient positioning. 12 papers from multiple institutions have already documented the reliable precision of BrainLAB x-ray IGRT systems 2,000 patients benefit from ExacTrac set-up precision annually in more than 15,000 individual treatment fractions Rapidly growing range of applications, including lung, solitary liver mets, spine, prostate, brain tumors and other recurrent small tumors ACCURACY EVERY TIME ExacTrac X-Ray 6D reliably provides high-accuracy image-guided set-up of the tumor isocenter: The system s accuracy can be represented with the mean threedimensional displacement vector, which yielded a three-dimensional uncertainty of 0.3 mm, with averages ranging from 0.0 to 0.3 mm 1 D. Verellen et al. The precision for a given isocenter between the simulation and the actual treatment position was within 1.36 mm ± 0.11 mm 2 S. Ryu et-al. With the image-guided patient positioning and target localization methods, the average isocenter deviation between the machine isocenter and the planned one is less than 2 mm 3 F.F. Yin et al. References: 1 D.Verellen et.al.; AQ of a system for improved target loc. and patient set-up that combines realtime IR tracking and stereoscopic X-ray imaging; Radioth. and Onc. 67 (2003) S.Ryu et.al.; Image-Guided and Intensity-Modulated Radiosurgery for Patients with Spinal Metastasis; CANCER April 15, 2003 / Volume 97 / Number 8 3 F.F. Yin et.al.; A technique of intensity-modulated radiosurgery IMRS for spinal tumors; Med. Phys. 29 (12), pp , (Dec 02)

4 MILLIMETER ACCURACY IN TWO MINUTES PRECISION & CONFIDENCE: EVERYTHING CHANGES ExacTrac X-Ray 6D provides millimeter-accurate target volume set-up through internal structure or implanted marker imaging. Two kv x-ray units, recessed into the Linac room floor, and two ceiling-mounted amorphous silicon flat panel detectors are combined with an integrated infrared tracking system that continuously monitors the patient s position throughout treatment. Increased 1-2 mm set-up precision 2-min. patient set-up for unrestricted throughput Optimization for most Linacs allows upgrading to IGRT independently of the standard replacement cycle WORKFLOW & THROUGHPUT: NOTHING CHANGES ExacTrac is designed for seamless integration into department workflows for uncompromised patient set-up. The software guides the user through an optimized workflow of image acquisition, set-up verification and automatic couch correction. With ExacTrac, patient throughput remains unchanged while treatment accuracy dramatically improves. EXACTRAC IGRT Patient enters Linac room Rapid patient pre-set-up for IGRT: Approximate skinmarker/laser alignment is sufficient since ExacTrac compensates automatically Pre-set-up completed Therapist exits treatment room ExacTrac set-up controlled from console room by therapist: stereoscopic x-ray imaging; automatic image verification and set-up calculation Robotic couch correction from console room Treatment Millimeter set-up accuracy Set-up completed 00:00 01:00 01:25 02:25 02:35 00:00 02:00 02:35 Patient enters Linac room Intensive manual set-up: Manual alignment of skin markers with laser; Significant therapist involvement and patient cooperation Set-up completed Therapist exits treatment room Treatment Conventional set-up accuracy CONVENTIONAL SET-UP

5 EXACTRAC X-RAY 6D

$The three-step process provides daily consistency in set-up verification and documentation, enabling a fast treatment workflow for every patient and every fraction.$ The therapist operates the entire x-ray acquisition and verification procedure from the console room, freeing time for the physician. 1.

The therapist operates the entire x-ray acquisition and verification procedure from the console room, freeing time for the physician. 1.

6 DAILY SET-UP CONSISTENCY STANDARDIZED IGRT WORKFLOW ExacTrac X-Ray 6D automates and standardizes patient set-up. The three-step process provides daily consistency in set-up verification and documentation, enabling a fast treatment workflow for every patient and every fraction. The therapist operates the entire x-ray acquisition and verification procedure from the console room, freeing time for the physician. 1. HIGH-RESOLUTION STEREOSCOPIC IMAGING The high-resolution stereoscopic x-rays are acquired immediately, saving the time normally needed to adjust the gantry. Gantry-independent x-ray technology for reliable accuracy Flexible x-ray imaging, even with rotated couch and gantry Quick-reference Digitally Reconstructed Radiographs (DRR) 2. SET-UP VERIFICATION IN 6D Within seconds, ExacTrac automatically verifies the x-rays and calculates the precise patient set-up for the treatment fraction. The system then displays the couch movements necessary to precisely align the patient s target volume to the Linac isocenter. Software-controlled image verification across 6 dimensions Consistent image verification eliminates variation from manual EPID correlation Automatic set-up verification within seconds, even during treatment delivery Calculation of reference DRRs from the planning CT images for automatic correlation with the live x-rays

3. CONTINUOUS POSITION MONITORING The ExacTrac X-Ray 6D robotic couch integration automatically moves the patient to the correct treatment position.

7 3. CONTINUOUS POSITION MONITORING The ExacTrac X-Ray 6D robotic couch integration automatically moves the patient to the correct treatment position. Integrated infrared patient tracking monitors the patient in real-time throughout the procedure, ensuring millimeter precision from the beginning to the very end of treatment. Optional x-ray verification and documentation images can be acquired at any point during treatment delivery. Automatic notification of patient movement beyond user-defined thresholds Positioning report with comprehensive graphical documentation on the patient set-up for each fraction ExacTrac tracking technology enables x-ray acquisition during the patient s breathing cycle, detecting target movement and enabling adaptive respiratory gating ROBOTIC PATIENT SET-UP ExacTrac is fully integrated with most treatment couches, closing the last gap in the chain of 6D IGRT localization, set-up verification and patient positioning. The ExacTrac interface for automatic couch motion provides the basis for fast, millimeter-precise patient set-up while the ExacTrac Robotics couch module provides robotic tilt correction of rotational set-up error. ExacTrac provides fast, flexible and automated patient set-up, saving time and reducing costs. Automated patient positioning for x, y, z and rotational axes Millimeter accurate positioning for both stereotactic and IMRT treatments Interface for automatic couch movement available for Varian and Siemens couches ExacTrac Robotics can be retrofitted to most treatment couches Robust and compact design allows patient-friendly access to treatment couch

ADAPTIVE GATING Images courtesy of Charité, Berlin, Germany 1. ACQUISITION OF INTERNAL TARGET MOVEMENT ExacTrac Adaptive Gating* enables precise IGRT for moving targets.

The intuitive software automates every treatment step: x-ray imaging correlated to the patient s breathing motion, image verification, patient set-up, beam gating and continuous tracking of patient

8 ADAPTIVE GATING Images courtesy of Charité, Berlin, Germany 1. ACQUISITION OF INTERNAL TARGET MOVEMENT ExacTrac Adaptive Gating* enables precise IGRT for moving targets. By correlating advanced x-ray imaging and external infrared tracking, ExacTrac can continuously track tumor movement in 3D. The intuitive software automates every treatment step: x-ray imaging correlated to the patient s breathing motion, image verification, patient set-up, beam gating and continuous tracking of patient breathing throughout the gated treatment. Real-time tracking of internal 3D tumor movement Clinically established gating solution for confidence in gated treatments Published millimeter precision for tumor set-up 2. AUTOMATIC BEAM GATING WITH X-RAY VERIFICATION The ExacTrac Adaptive Gating module continuously tracks the patient s 3D breathing pattern in real-time, triggering the Linac beam only when the tumor is on target. ExacTrac Adaptive Gating provides the highest level of clinical confidence. Multiple x-ray verification shots may be taken independently of the gantry position and at any time throughout dose delivery. This allows the user to verify, despite breathing movement, that the patient s target is always at the isocenter position during treatment. Total time for gated treatments ranges from min. Infrared-triggered gating reduces imaging dose compared to fluoro approaches Automatic beam triggering through full safety integration with most Varian and Siemens Linacs

IMPLEMENTED IN DAILY PRACTICE In the past, highly focused dose delivery to tumors subject to respiration-induced movement was impossible.

ExacTrac Adaptive Gating enables a significant reduction of safety margins.

Recent studies have shown that up to 50% of normal tissue can be spared from radiation using adaptive gating 1, contributing to reduced side effects and better treatment outcomes.

9 IMPLEMENTED IN DAILY PRACTICE In the past, highly focused dose delivery to tumors subject to respiration-induced movement was impossible. Today, ExacTrac Adaptive Gating detects the exact location of a moving target in real-time, enabling respiration-triggered dose delivery. ExacTrac Adaptive Gating enables a significant reduction of safety margins. This is crucial for lung and liver indications, where large margins are traditionally applied to ensure the tumor is covered with a sufficiently high dose. Recent studies have shown that up to 50% of normal tissue can be spared from radiation using adaptive gating 1, contributing to reduced side effects and better treatment outcomes. Inhale: beam halted to spare normal tissue ADAPTIVE GATING CLINICAL PARTNERS Leading institutions have partnered with BrainLAB to revolutionize lung and liver treatments using ExacTrac Adaptive Gating. Cleveland Clinic, Cleveland, OH Henry Ford Hospital, Detroit, MI MD Anderson, Orlando, FL UCLA, Los Angeles, CA AZVUB, Brussels, Belgium Charité University Hospital, Berlin, Germany Vrije University, Amsterdam, Netherlands Exhale: beam enabled to deliver treatment dose to the tumor *BrainLAB Adaptive Gating received FDA clearance in December 2003; commercial availability is currently pending. 1 R. Underberg, et al.; VU Med. Canter Amsterdam, The Netherlands; Benefit of Respiration-Gated Stereotactic Radiotherapy for Stage I Lung Cancer...; Int J Radiat Oncol Biol Phys, Vol. 62, No. 2, pp , 2005

CLINICAL CASE REPORT PROSTATE CANCER TREATMENT WITH X-RAY IGRT Patrick Kupelian, M.D.

$IMRT 78 Gy at 2 Gy per fraction to the prostate and seminal vesicles. Three gold markers placed in the prostate transrectally under ultrasound guidance. irradiated area bladder IGRT PROCEDURE STEPS 1.$ Acquisition of two high-resolution x-rays prior to treatment to determine the 3D position of the PTV (via implanted markers). 3a.

Acquisition of two high-resolution x-rays prior to treatment to determine the 3D position of the PTV (via implanted markers). 3a.

10 CLINICAL CASE REPORT PROSTATE CANCER TREATMENT WITH X-RAY IGRT Patrick Kupelian, M.D.; M.D. Anderson Cancer Center, Orlando, FL PATIENT 60-year-old-male, prostate cancer stage T1c, Gleason s grade 6/10, PSA 8.2 ng/ml. IMRT 78 Gy at 2 Gy per fraction to the prostate and seminal vesicles. Three gold markers placed in the prostate transrectally under ultrasound guidance. irradiated area bladder IGRT PROCEDURE STEPS 1. Patient pre-positioning with skin markers and lasers. Therapists exit the treatment room and control the IGRT set-up from the console area. 2. Acquisition of two high-resolution x-rays prior to treatment to determine the 3D position of the PTV (via implanted markers). 3a. With Implanted Markers: Determination of markers on the x-rays and automatic calculation of the patient set-up error. 3b. Without Implanted Markers: Automatic real-time verification of live x-rays with Digitally Reconstructed Radiographs (DRRs) calculated inside the system using the initial CT planning data. The software algorithm uses bony anatomy to align both live x-rays and DRRs to calculate x,y,z and rotational set-up errors. A trained therapist operates and reviews the fully automated image verification. 4. Detected set-up deviations are subsequently corrected by applying the required translational shifts to the robotic treatment couch from outside of the treatment room. The treatment set-up was guided with the infrared module. 5. IMRT delivery administered under continuous infrared tracking. TIME REQUIREMENT FOR PATIENT SET-UP PROCEDURE At our institution, the IGRT procedure outlined above takes 2-3 min. on average. The accuracy provided by the system allowed us to reduce the need for other measures to ensure proper patient set-up. The fast set-up of the system allows us to utilize this IGRT approach with all of our prostate patients. right hip rectum prostate left hip Prostate IMRT treatment planned with the confidence of having millimeter positioning accuracy. Stereoscopic digital x-rays are acquired immediately prior to treatment to visualize internal anatomy or implanted marker positions for determination of the PTV s current position. POST-PROCEDURE WORK Daily image review and comparison with previous shifts. Feed-back communicated to the therapists about the adequacy of registrations and, if necessary, about the steps necessary to take to improve future registrations. Set-up documentation and final physician approval can be done electronically or via print-outs. ACCURACY OF THE PATIENT POSITIONING SYSTEM Several publications report an average positioning accuracy of around 1 mm for the planned isocenter using the BrainLAB x-ray positioning system 1,2. Our own accuracy tests are in agreement with those publications. References: 1 Yan H, Yin FF, Kim JH; A phantom study on the positioning accuracy of the Novalis Body system. Med Phys Dec; 30(12): Ryu S, Khan M, Yin FF, Concus A, Ajlouni M, Benninger MS, Kim JH; Image-guided radiosurgery of head and neck cancers. Otolaryngol Head Neck Surg Jun;130(6):690-7

Liver metastases were diagnosed six months after surgery and successfully treated with chemotherapy. In February 2005, two new liver metastases were diagnosed.

11 CLINICAL CASE REPORT LIVER TUMOR TREATMENT WITH STEREOSCOPIC X-RAY GUIDANCE AND ADAPTIVE GATING Reinhard Wurm, M.D. University Hospital Charité, Berlin, Germany PATIENT 60-year-old male, first diagnosed in May 2003 with cancer of the rectum pt1pn0 (0/33), L0, V0, R0. Liver metastases were diagnosed six months after surgery and successfully treated with chemotherapy. In February 2005, two new liver metastases were diagnosed. It was decided to treat the patient with extra-cranial stereotactic radiotherapy (SRT) with adaptive gating under stereoscopic x-ray guidance during treatment. One spiral marker was placed inside the liver metastasis under ultrasound guidance. The patient then received hypo-fractionated SRT with seven coplanar individually-shaped conformal beams with 79.2 Gy at the isocenter and the 80% isodose line encompassing the target, given in 11 fractions, 5 times per week. The safety margin was 5 mm in all directions. GATING PROCEDURE STEPS FOR LIVER TUMORS Our typical workflow for gated radiotherapy using ExacTrac : 1. Automatic patient pre-positioning using the ExacTrac couch integration; detection of the patients breathing signal using infrared tracking and reflective body markers on the patient s chest. 2. Acquisition of three pairs of high-resolution x-rays at defined points along the patients breathing cycle to determine the 3D position and respiration-induced motion of the tumor. 3. Automatic calculation of the patients set-up position for treatment and display of the extent of tumor movement. 4. Subsequent correction of the detected set-up deviations by applying the required translational shifts with the robotic treatment couch; patient set-up is performed from outside of the treatment room and is guided in real-time with the system s infrared tracking. 5. Definition of the beam-on window based on the extent of tumor motion and chosen safety margin of the PTV. 6. Gated delivery with automatic beam-on/off control; verification x-ray images during treatment to verify tumor set-up. TIME REQUIREMENT FOR PATIENT SET-UP AND GATED DELIVERY The image-guided adaptive gating treatment took an average of 30 minutes to complete. The system s accuracy allowed us to reduce the need for other measures typically performed in patient set-up verification. The 7D set-up (three translational dimensions, three rotational axes and time) and the gated delivery allowed a reduction in the safety margins which are normally applied to compensate for inaccurate set-up and target motion. Published data report an average accuracy of around 1 mm for patient set-up using the stereoscopic x-ray positioning system 1,2. With the adaptive gating approach, comparable set-up accuracies are now achievable for moving targets. Gated liver stereotactic treatment, planned with the confidence of having millimeter dose delivery accuracy. Stereoscopic digital x-rays are acquired prior to and during treatment to visualize an implanted marker to determine the PTV s current position, extent of tumor motion and beam-on window. References: 1 Yan H, Yin FF, Kim JH. A phantom study on the positioning accuracy of the Novalis Body system. Med Phys Dec;30(12): Ryu S, Khan M, Yin FF, Concus A, Ajlouni M, Benninger MS, Kim JH. Image-guided radiosurgery of head and neck cancers. Otolaryngol Head Neck Surg Jun;130(6):690-7

12 USA us_sales@brainlab.com Germany de_sales@brainlab.com Hong Kong hk_sales@brainlab.com brainlab.com Australia / New Zealand au_sales@brainlab.com Brazil br_sales@brainlab.com China cn_sales@brainlab.com France fr_sales@brainlab.com Iberica es_sales@brainlab.com India in_sales@brainlab.com Italy it_sales@brainlab.com Japan jp_sales@brainlab.com Korea kr_sales@brainlab.com Malaysia my_sales@brainlab.com Middle East me_sales@brainlab.com UK uk_sales@brainlab.com 2005 BrainLAB AG. Printed in Germany. RT-BR-E-IGRT 0705 Q:4000 registered trademark of BrainLAB AG in Germany and / or the US. *Availability in the US pending.

EXACTRAC HIGHLY ACCURATE PATIENT MONITORING

EXACTRAC HIGHLY ACCURATE PATIENT MONITORING PATIENT POSITION MONITORING ExacTrac is an in-room based monitoring system that detects intrafractional motion during treatment delivery. Two kv X-Ray units