Radiosurgery of the head and neck with the world`s first fully
Transcription
Radiosurgery of the head and neck with the world`s first fully
Radiosurgery of the head and neck with the world’s first fully robotized 192 Cobalt-60 source Leksell Gamma Knife Perfexion in clinical use Jean Régis, Manabu Tamura, Cécile Guillot, Xavier Muracciolle, Mariko Nagaje, Denis Porcheron. Correspondence : Professeur Jean Régis Hôpital d'adulte de la Timone, Service de Neurochirurgie Fonctionnelle & Stéréotaxique, 264 Rue Saint Pierre, 13385 Marseille Cedex 05 FRANCE jregis@ap-hm.fr Radiosurgery of the head and neck with the world’s first fully robotized 192 Cobalt-60 source Leksell Gamma Knife Perfexion in clinical use JEAN RÉGIS, MANABU TAMURA, CÉCILE GUILLOT, XAVIER MURACCIOLLE, MARIKO NAGAJE, DENIS PORCHERON. * Stereotactic and Functional Neurosurgery, Timone University Hospital, Marseille, France ** Radiation Oncology Department, Timone University Hospital, Marseille, France. Object: The world’s first Leksell Gamma Knife® Perfexion™ for radiosurgery of the head and neck became operational at Timone University Hospital of Marseille on July 10th 2006. In order to strictly evaluate the new capabilities, advantages, disadvantages and limits of this new technology, patients have been included in a prospective trial. Preliminary results of this trial are presented. Methods: In 17 working days between July 10th and September 10th 2006, 83 patients were operated by Gamma Knife surgery in Timone University Hospital of Marseille. Among these, 59 patients were eligible for the comparative prospective study (informed consent signed, tumoral or vascular indication, no previous radiosurgery or radiotherapy). In accordance with the blinded randomization process 29 patients were treated with Leksell Gamma Knife 4C and 30 patients with Leksell Gamma Knife Perfexion. Dose planning parameters, dosimetry measurements on the patients body, workflow, patient comfort, QA procedure and a series of other treatment related parameters are systematically and prospectively evaluated in both arms. Results: No technical failures occurred in either arm of the study. The new dose planning system led to the use of composite shots in 46,7% of the patients. The mean number of different collimator sizes used was larger with the Perfexion unit than with 4C, 2,23 and 1,57 respectively. The mean number of isocenters used was lower (10,80 vs. 13,76). The median total treatment time was significantly shorter with Perfexion (44,5 min vs. 65 min) while the median radiation time was similar in both machines (34,67 min vs. 36,37 min). The procedure was performed using a single run in all the Perfexion cases. With the 4C this was possible in only 37,9% of the cases. Collision risk on the 4C forced us to change the frame gamma angle for at least one shot in 27,6% of the patients and led to treatment in manual mode for at least one shot in 20,7% of the patients. Collision risk requiring technical adjustment was never observed with Perfexion. In one patient treated on Perfexion the system required a direct collision check. Compared with the 4C Perfexion delivers 8.2 times less dose to the vertex, 10 times less dose to the thyroid, 12.9 times less dose to the sternum and 15 times less dose to the gonads. Conclusions: This preliminary analysis of our prospective data indicates that procedures with Perfexion were collision-free even with extreme location of the lesion (e.g. multiple metastases). The duration of the surgical procedure, duration of nurse, physicist and physician intervention on the machine, and the duration of the QA procedure are all dramatically reduced with the Perfexion unit. Radiation protection, already very good with the Leksell Gamma Knife 4C, is strongly improved with the Perfexion unit. In our experience, Leksell Gamma Knife Perfexion incorporates technological advances that will contribute to very significant future progress in head and neck radiosurgery. KEY WORDS: radiosurgery . stereotactic radiotherapy . vestibular Schwannomas . arteriovenous malformation . robotisation. 3 FIG 1: The world’s first Leksell Gamma Knife Perfexion installed at Timone University Hospital. Introduction In 1951, Lars Leksell introduced the concept of radiosur3 gery. His intention was to create a technique relying on the use of a large number of converging beams of ionizing radiation to induce a small volume of necrosis in the target area. After several disappointing attempts using moving beams, Leksell and Larson created the first fixed 4 source cobalt 60 unit called Gamma Knife. Gamma Knife 5 surgery (GKS) gained worldwide acceptance in the 80's, together with the emergence of modern imaging, particularly magnetic resonance imaging (MRI) which contributed greatly to improve the safety and efficacy of radiosur2 gery. Development of workstations and planning software enabled three-dimensional radiosurgery planning with simultaneous calculation of 3D dosimetry and with 3D anatomical imaging reconstruction allowing better 10 control of 3D conformity and selectivity. The addition of robotic technology (automatic positioning system – APS) 11 improved patient and medical team comfort. In 2002, a FIG 2: The fixation system is extremely simple and the hidden location of the motors at the rear of the machine leaves a lot of space for patient positioning and comfort. 4 FIG 3: TLD’s (thermoluminescent dosimeters) are positioned on the vertex, lens, thyroid, sternum and pelvis on all patients included in the prospective trial. group of international experts were asked to define the requirement specifications for a new Gamma Knife. The new machine was to be designed such that it matched or exceeded all the technological and medical requirements of the very experienced group of experts. The expert group concluded that the basic principle of multiple con8,12 verging fixed beams and patient immobilization with the stereotactic frame provided the most reliably precise and accurate radiosurgical solution. However, in order to meet future specific indications for stereotactic radiotherapy, a technologically user friendly frameless fixation solution was also desired. The group agreed on five critical features: best dosimetry performance, best radiation protection for patient and staff, unlimited cranial reach, full automation and outstanding patient and staff comfort. Based on these specifications Elekta Instrument AB developed a completely new radiosurgical instrument which FIG 4: The original design of the Perfexion. Eight sectors, containing 24 Co60 sources each, are moved by 8 servo drives (see Fig. 6). Depending on the sector position the collimator size can be 4 (A), 8 (B) and 16 mm (C) or Blocked/off (D). they humbly named Perfexion. The Marseille Timone University neurosurgical group was identified as a good site for a first installation of this extensively revised and CE marked radiosurgery platform (Fig. 1). In order to strictly evaluate this new technology and with funding from APHM (Assistance Publique Hôpitaux de Marseille) and ethics committee (CPPRB1) approval, we organized a randomized prospective controlled trial. Material and Methods In 17 working days between July 10th and September 10th 2006, 83 patients were operated by Gamma Knife Surgery in Timone University Hospital of Marseille. Among these, 59 patients were eligible for the comparative prospective study. These 59 patients were randomized to undergo Gamma Knife Surgery using either Leksell Gamma Knife 4C® * in 29 patients or Leksell Gamma Knife Perfexion® ** in 30 patients. The goal of this prospective randomized controlled trial is to identify differences between these two instruments in a population of 200 patients. The study is designed as a controlled randomized comparative prospective study. Ethics committee (CPPRB1) approval has been obtained. The study is conducted under the control of the health authorities. Any severe adverse events will be reported to these authorities. Patients eligible are older than 18 years, selected to undergo Gamma Knife surgery for an intracranial lesion (vascular or tumoral) with signed informed consent. Furthermore, eligible patients are not included in any other trials and have never been treated with radiotherapy or radiosurgery for the same lesion. In women possibility of pregnancy or breast feeding are exclusion criteria. Irradiation time, treatment time, treatment room occupation time, dose planning parameters, dosimetry measurements on the patients body, workflow, patient comfort, QA procedure and a series of other treatment related parameters are systematically and prospectively evaluated in both arms. The loading of the 192 Co60 sources of the Perfexion unit and the reloading of the 201 Co60 sources of Leksell Gamma Knife 4C were both accomplished after the installation of the new machine. All sources came from the same supplier and had uniform dose rate. The dose rate of the machines are very slightly different at 3,628 Gy/min vs. 3,756 Gy/min. *, ** Elekta Instrument AB, Stockholm, Sweden 5 Workflow Workflow evaluation data is summarized in table 1. For the Perfexion and the 4C the median total time spent by each patient in the Gamma Knife operating room was 44,5 min vs. 65,0 min respectively and the median “beam on” time was 34,67 min vs. 36,37 min. FIG 5: The servo drives. Posterior view of the Perfexion machine, with the posterior cover removed, showing the servo drives and the computer system controlling the movements of each sector. The Procedure The procedure started with application of the Leksell® Stereotactic Frame to the patient’s head, under local anesthesia. After frame fixation, MR and CT scans were obtained for dose planning with Leksell® GammaPlan (LGP). Before every case the MR scanner was calibrated before examination and the scans verified by comparing them against the CT images in order to minimize magnetic distortion errors. Stereotactic angiograms were obtained only for AVM cases. Based on these images treatment planning (target localization, definition of boundaries, localization of surrounding radiosensitive structures and dose determination) was performed using the Leksell GammaPlan® PFX™ release 7.0 and Leksell GammaPlan 4C release 5,34 respectivly for patients treated with the Perfexion unit and 4C. Patients were positioned in the machine and the appropriate check procedure performed (Fig. 2). 1,6,13 were Thermoluminescent dosimetry (TLD) detectors positioned on the vertex, lens, thyroid, sternum and pelvis before the start of the procedure (Fig. 3). Leksell Gamma Knife Perfexion or Gamma Knife 4C procedures proceeded according to the routines of the department and the patients were discharged within 24 hours after radiosurgery. All procedures were performed by the same neurosurgeon (JR). To secure the reliability of data collection a dedicated clinical research assistant was in charge of data collection and management (CG). Before discharge each patient was asked to complete a brief questionnaire providing their overall judgment about the comfort of the procedure (scores were good, acceptable or bad for each question). Results Technical Performance No technical failures were encountered in either arm of the study and up-time was 100% for the new machines. 6 Dosimetry Technique With the Perfexion unit the technique for dosimetry has been significantly modified as compared with the 4C (Table 2). Comparison of dose planning strategies using Leksell GammaPlan PFX and Leksell GammaPlan 4C shows a significant reduction of the number of runs when using Perfexion. The procedure was performed using a single run in all the Perfexion cases. With the 4C a single run was possible in only 37,9% of the cases. The total number of shots was significantly reduced with a mean number of isocenters of 10,80 with Perfexion versus 13,76 with the 4C. The mean number of different collimator sizes used in a single patient was larger with the Perfexion unit (2,23 vs 1,57). With Leksell Gamma Knife Perfexion it is possible to use hybrid (or composite) shots, i.e. mixing different collimator diameters in an individual shot. This allows increased use of shielding and thus improved protection of critical structures. The new dose planning system led to the use of composite shots in 46,7% of the patients. The median number of composite shots used per patient is two. Shielding was used for at least one shot in only 3,4% of the patients treated with the 4C and in 50% of the patients treated with Leksell Gamma Knife Perfexion. TABLE 1: A Comparison of workflow parameters on both machines clearly demonstrates a dramatic time reduction for all phases of the procedure. The total time spent per patient in the Gamma Knife operating room is very significantly reduced with Perfexion. The difference in the total “beam on” time differs less between the two machines. The most dramatic time reduction was related to the phase of setting the patient up in the treatment room and, to a lesser extent, to the reduction of the irradiation time. Time in min LGK C median Standart deviation Mean dev. Perfexion median Standart deviation Mean dev. Total Time in the Treatment room* «Beam On» Time diff 65 39,98 32,0 36,37 22,28 17,3 26,34 22,80 18,8 Total Time in the Treatment room Total Treatment Time diff 44,5 37,06 33,90 34,67 27,94 21,60 8,36 13,52 15,29 * From patient installation in the machine to final closure of shielding doors. improvement of comfort particularly in terms of comfort for the shoulders and the back of the patient. A significant improvement is also noted in terms of anxiety caused by confinement (claustrophobia). Body Dosimetry The results of dose measurements to other parts of the body are summarized in table 4. Compared with the 4C unit the Perfexion unit delivers 8.2 times less dose to the vertex, 10 times less dose to the thyroid, 12.9 times less dose to the sternum and 15 times less dose to the gonads. Discussion We are reporting on the very first experience with a new radiosurgical instrument developed by Elekta Instrument AB, the Leksell Gamma Knife Perfexion (Fig. 1). These preliminary findings are based on the prospective evaluation of 59 patients fulfilling inclusion and exclusion criteria and randomized to undergo radiosurgery using either Leksell Gamma Knife 4C® or Leksell Gamma Knife Perfexion® . FIG 6: The QA system allows real time measurement of the accuracy in dose delivery. This is a fast and fully automated procedure giving an immediate result. Collision Risk Collision risk is determined before starting the procedure. Through a “dummy run” it is possible to assess whether any parts of the stereotactic frame will hit the inside of the collimator body during the automated treatment. A risk for collision was predicted by GammaPlan for at least one shot in 48,3% of the patients treated with the 4C and in only one patient (3,3%) with the Perfexion. In this single case a direct check of the absence of collision was required by the system. Collision risk requiring technical adjustments was never observed with Perfexion. With the 4C collision risk forced us to change the frame angle for at least one shot in 27,6% of the patients and to use manual (trunnion) mode for at least one shot in the treatment of 20,7% of the patients. Until now we have had no instance of collision using the Perfexion unit. Manual mode treatments are not provided for using Perfexion. Patient Comfort The patient evaluation of procedure comfort is summarized in table 3. The questionnaire completed by the patients before being discharged demonstrates a significant TABLE 2: Comparison of dose planning strategies on GammaPlan PFX 7.0 & 4C 5,34 demonstrating the significant reduction of the number of runs (with Perfexion all procedures were completed with a single run), the significant reduction of the total number of shots, the use of hybrid (or composite) shots, the increase in the number of different size collimators used in a single patient, the increased use of shielding for protection of critical structures, the dramatic decrease of collision risk, the disappearance of technical adjustments required due to collision risk (no gamma angle change, no trunnion mode use, no eccentric frame positioning). With Perfexion we have so far noted complete absence of true collisions. % of treatment with 1 run composite plug shot Angle different from 90° Collision Risk Trunion LGK C 37,9 NA 3,4 27,6 48,3 20,7 Perfexion 100 46,7 50,0 0 3,3 NA LGK C run shots composite shot collimatorused Trunion** Median 2 12 2,48 13,76 Mean Standart deviation 2,05 11,44 Mean dev. 1,4 9,3 Perfexion run per run* 0 0 0 0 2 1,57 0,50 0,5 2 4,5 2 3,25 shots composite shot collimator used Trunion** Median 1 10 1,00 10,80 Mean Standart deviation 0,00 7,28 0,00 5,99 Mean dev per run* 2 1,77 0,87 0,71 2 2,23 0,82 0,70 NA * ”Composite shots per run” is the number of hybrid shots in those patients in whom at least one hybrid shot was used. ** This is the number of shots done in trunnion mode in those patients treated with at least one shot in trunnion mode. Trunnion mode means manual setting of the coordinates. 7 FIG 7: Treatment of eccentrically located lesions. Dose planning on the same day of 4 brain metastases in extreme and opposite locations (frontal anterior, far lateral and posterior fossa) with no collision concern, few constraints on frame positioning and no requirement for technical adjustments, e.g. changing of frame angle, trunnion mode etc. Note that each lesion is treated very easily with a single isocenter. In order to shape the dose plan to make it fit with the lesion, two shots are hybrids (mixing 8 and 16 mm collimators) and one shot has three sectors blocked (72 beams). Preservation of Fixed Converging Beams Design The preservation of the multiple fixed converging beam design of Leksell Gamma Knife Perfexion gives this system the advantage of being able to rely on the very large and prolonged worldwide clinical experience gained to date, as well as on the thousands of peer-reviewed papers published by teams operating their patients using Leksell Gamma Knife. Specific Perfexion Design The original design of the Perfexion unit is based on a single, integrated permanent collimator system that incorporates openings for collimators of 3 different diameters (Fig. 4). The collimators are partitioned into eight segments around the circumference of the device, each containing an independently moveable sector. These eight sectors, each containing 24 Co60 sources, are operated by individual servo drives (Fig. 4 & 5). Depending on the sector position the collimator size of each sector can be individually varied between 4, 8 and 16 mm or be blocked (off) (Fig. 4). 8 Complete Automation The design of the Perfexion allows full automation of the whole surgical procedure. Both beam configuration and coordinate settings have been automated which greatly alleviates the workload of the staff. Beam Off The beam off position, which is possible independently in each one of the eight sector, significantly increases flexibility in beam shaping thus increasing the possibilities when protection of surrounding critical structures becomes important. Also, and importantly, the possibility to turn off all the beams allows changing of the x, y and z coordinates without moving the couch and the patient out of the machine. These are the steps in the procedure where Perfexion saves the most time. With the 4C unit, moving the couch in and out of the radiation unit in order to reposition for a new shot takes 30 seconds per shot and each time the collimator needs to be reconfigured takes an additional approximate 10 minutes. With the Perfexion unit this time has been reduced to almost zero. FIG 8: Dose planning using dynamic shaping in a patient presenting with a secreting pituitary adenoma (growth hormone). The patient was previously operated but still presents with aggressive disease. The dynamic shaping process was initiated after a very conformal and selective dose plan had been produced. Dynamic shaping allowed a further significant reduction of dose to the visual pathways. A dose of 25 Gy at the 50% isodose was selected. This is a rather high dose at this location and for a lesion of this size (3300 mm3). A level 2 setting for sensitivity of the dynamic shaping process was sufficient to obtain an acceptable dose to the visual pathways (less than 8 Gy) Note the flexibility of the dose planning and the versatility of the solution developed for each shot. With just 14 shots we were able to obtain a very conformal plan. Darken Shaded sectors are blocked as an effect of the activation of the dynamic shaping process (in two critical shots). Among the 14 shots only one is a full collimator (8 sectors at 4mm). In 10 shots between 1 and 4 sectors were blocked in order to better adapt the shot to the anatomy (taking into account both the lesion itself and surrounding critical structures). Six out of fourteen shots were mixed. Limitations There are some potential limitations with the Perfexion unit. The system is designed in such a way that a manual treatment mode is no longer possible. This is probably a relative limitation given the extensive testing that went into the verification of the design. In our experience the reliability of the device is remarkable. In our center this is definitely of no concern since we have both systems working in parallel. The sector system is a technological choice with a lot of virtues but also one theoretical limitation which is that limited plugging of only a handful of beams is no longer possible. In practice so far we have been indifferent to this theoretical limitation. The design with plugging of entire sectors (24 sources) has turned out to be very well adaptated to the task of protecting surrounding critical structures. Full robotization means no direct human checking of coordinate settings or collimator selection for each shot. TABLE 3: Patient comfort during the procedure. A questionnaire completed by the patients before discharge shows a significant improvement of comfort, particularly in terms of strain on shoulders and back as well as anxiety related to confinement (claustrophobia). Rating Overal The site experience Shoulder Back Claustrophobia LGK % Good % OK % Bad 67,9 28,6 3,6 100,0 84,0 8,0 7,1 99,1 71,4 25,0 3,6 100,0 64,3 25,0 10,7 100,0 78,6 17,9 3,6 100,0 % Good % OK % Bad 70,4 29,6 0,0 100,0 95,8 4,2 0,0 100,0 88,9 7,4 3,7 100,0 85,2 11,1 3,7 100,0 85,2 7,4 7,4 100,0 PFX 9 Quality Assurance System The QA system of the Perfexion unit allows direct measurement display of the dose delivery diagram in real time (Fig. 6). This is a real advantage and an important improvement of the QA procedure. User Friendliness Ease of use is the first obvious advantage of this device over all pre-existing radiosurgical systems. When dose planning is finalized and the plan has been exported to the treatment machine only a few minutes of work remain for the physician. The treatment is performed using a single run and patient positioning in the machine is extremely simple (Fig. 2). When treatment planning has been completed and the plan exported only three task remain before initiating the procedure on the Perfection: 1. To position the patient on the couch in a way that optimizes patient comfort 2. To connect the head frame to the couch 3. To check and confirm patient identity using a single button 4. Couch and patient are no longer moving in and out of the machine. This is appreciated by the patients and significantly reduces total treatment time. 5. Radiation outside of the treatment machine has been reduced to a level so low that we have been allowed to separate the treatment and control rooms with just a large window of ordinary glass (Fig. 9). Patients no longer have the unpleasant feeling of being completely isolated. They can see the staff and their family through the window. This is a real contribution to the psychological comfort and well-being of the patient. 6. Anxiety caused by confinement (claustrophobia) has been much reduced in the new machine, largely due to the important increase of space inside the collimator body. Collimator Size The size of the collimator body in Perfexion is three times larger than the previous collimator helmets. This is a major change that has four main positive consequences: Alltogether these three steps require a few seconds. 1. Patient Throughput Speed of patient throughput is very much improved (Table 1). The reduction of the total treatment time is mainly related to 4 factors: The risk for collision is dramatically reduced or entirely removed. This in turn has obviated the need for eccentric frame positioning thereby increasing patient comfort. 2. Classical indications for radiosurgery in peripheral locations such as around the foramen magnum or ophthamological conditions are now easily and comfortably treated. 3. Multifocal lesions such as multiple metastases are easy to treat in a single run even if very excentrically located (Fig.7). Trunnion mode is no longer needed nor is frame repositioning, consequences which bring tremendous time savings. 4. Extended reachability to head and neck areas previously unreachable will soon lead to a major expansion of radiosurgical indications. Lesions in and around the paranasal sinuses, the orbits, the cervical spine and the pharyngo-laryngeal area are now accessible. A specific fixation device for head and neck lesions is under development. 1. All patients are treated in a single run 2. Full automation has made all manual interference redundant 3. The full off position enables coordinate resetting without withdrawal of the couch 4. Patient positioning and initiation of treatment are three extremely easy and swift steps Patient Comfort Patient comfort has been greatly improved as illustrated by the summary of patient questionnaires (Table 3). We can identify at least 6 major reasons for this. 1. The motors driving the system are no longer located in the patient space but have been integrated in the core of the machine, thereby significantly improving the space around the patient’s body and shoulders. 2. The inside of the collimator body being three time larger than the previous collimator helmets of the 4C, there is much less need for eccentric frame positioning. Such frame positioning can sometimes be quite unpleasant for the patient. 3. Positioning of the surgical target at the point of beam intersection is accomplished by moving the couch around that point. There is no longer any tension or stress exerted on the neck of the patient. 10 Extended Anatomical Reach Head and neck extended reachability will in the near future lead to a major enlargement of radiosurgery indications. The new adaptor for frames which is located on the top end of the couch is very versatile and has been designed to welcome a new family of different frames intended for different applications. One of the first frames of this family under development is a fixation device for cervical spine lesions. A repositionable frame dedicated for stereotactic radiotherapy is also expected. Flexibility in Dose Window A B C D FIG 9: Timone Hospital installation of the Perfexion in the special operating room. Note the window in floorplan (A) which was made possible by the very low amount of leakage radiation with the Perfexion. Measurements are given at 1 m above floor before loading of the sources (B) in beam off state (C) and beam on state (D). The spacing of the grid is 0.5 m. No other horizontal plane contains dose rates higher than this plane. Dose rates are in µSv/h. Dose rates in locations with no specified value are less than 2 µSv/h. 11 Planning Dose planning is gaining flexibility with the sector philosophy. The major dose planning changes in practice are related to three factors: 1. Complete automation allows the use of as many collimators as desired without any manual interaction. 2. Shielding no longer requires manual work. The increases the use of plugging which will lead to further refinement of treatment plans. 3. The new possibility to create hybrid isocenters (also called composite shots) provides new flexibility in sculpting single shots both by relying on the use of plugging and by mixing different size collimators (Fig. 8). Conventional planning using 4, 8, and 16 mm collimators is done very similarly on both GammaPlan PFX and GammaPlan 4C. The two GammaPlan platforms are very similar in this respect and a classic multi-isocentric plan7 can be done with little training. However, the moving sector principle of Perfexion is opening the field to hybrid isocenters which is very new and will require more training. Body Dosimetry Dosimetry on different parts of the body during the procedures has been shown to be particularly satisfactory in Gamma Knife radiosurgery as compared to alternative 13 radiosurgical techniques. Radioprotection is increasingly considered as a major and important aspect of radiation medicine. The majority of patients operated with radiosurgery are presenting with a benign condition and a rather normal life expectancy. Measurements in the Perfexion operative room are extremely low (Fig. 9). Radiation during patient couch transit have been reported as contributing little to the doses at the measured extra 9,13 cranial sites. However, the increased robotization and automation of the Gamma Knife has led to a dramatic increase of the number of isocenters used and thus to a 11 slight increase in transit dose. In Perfexion this has been addressed by incorporation of the all beams off feature (Fig. 4). Also, the more liberal use of plugs has been said to increase the extra cranial dose.1 Our preliminary comparative dosimetry measurements have demonstrated a significant reduction of the dose delivered to the body. This is preliminary analysis of our initial experiences. It will require further confirmation with more extensive experience and additional evaluation of the impact of the Leksell Gamma Knife Perfexion. Long term clinical outcomes remain the most important factor for clinicians in their assessment of new technologies. Nevertheless, the preservation of the converging fixed beams design allows us to be very confident in the continued high quality of the long term clinical outcomes achieved so far with Gamma Knife surgery. 12 TABLE 4: Median dose measured on the body (the vertex, thyroid, sternum and gonads), both in patients treated with the Perfexion and those treated with the gamma Knife 4C, demonstrating a dramatic reduction of the doses delivered to these structures in patients treated on the Perfexion. Perfexion is delivering 8.2 times less dose to the vertex, 10 times less dose to the thyroid, 12.9 less dose to the sternum and 15 times less dose to the gonads. The values relative to the lens will be presented in a future paper. Perfexion LGK 4C vertex 3026507 Median 2701427 St dev 2116051 thyroid 853270 668207 665419 sternum 424043 257955 416464 gonads 173147 47120 340456 Mean Median St dev Factor 8546115 8475738 5887574 10,0 5479509 5183195 3715282 12,9 2590071 1686158 2474649 15,0 24766524 29673594 14305340 8,2 Conclusions In this preliminary experience Leksell Gamma Knife Perfexion is turning out to represent a great improvement other radiosurgical technologies and even over earlier Gamma Knife systems. We have been able to verify that Perfexion fulfills all requirements submitted by the Expert Group while also preserving the operational characteristics and identity of Gamma Knife which have made it the gold standard radiosurgery instrument for decades. The workflow improvement has surpassed all expectations. Fully integrated robotization is giving more freedom to the dose planning process and is even creating new opportunities for further dose planning refinements with hybrid shot availability. The dramatic increase of the treatable volume by over 300% is already improving patient and staff comfort and is also expected to expand greatly radiosurgery's role in the head and neck and cervical spine areas. Our overall feeling is that this new generation of platform for radiosurgery is a real quantum leap for radiosurgery technology and appears to make radiosurgery even easier, faster and safer than before. However, longer follow up and more extensive experience is required before drawing any kind of definitive conclusions. We may well be looking at the dawn of a new era for radiosurgery. References: 1. Desmedt F, Vanderlinden B, Simon S, Paesmans M, Devriendt D, Massager N, Ruiz S, Lorenzoni J, Van HP, Brotchi J, Levivier M: Measurements of Extracranial Doses in Patients Treated with Leksell Gamma Knife C. Presented at ISRS, 2004. 2. Flickinger JC, Kondziolka D, Pollock BE, Lunsford LD: Evolution in technique for Vestibular Schwannoma Radiosurgery and Effect on Outcome. Int. J. Radiation Oncology Biol. Phys. 36:275-280, 1996. 3. Leksell L: The stereotaxic method and radiosurgery of the brain. Acta Chirurgica Scandinavia 102:316-319, 1951. 4. Leksell L: Stereotaxis and radiosurgery. An operative system, in Thomas CC (ed), Springfield, 1971. 5. Lunsford LD, Flickinger JC, Lidner G, Maitz A: Stereotactic radiosurgery of the brain using the first United States 201 cobalt-60 source gamma knife. Neurosurgery 24:151-159, 1989. 6. Ma L, Chin L, Sarfaraz M, Shepard D, Yu C: An investigation of eye lens dose for gamma knife treatments of trigeminal neuralgia. J Appl Clin Med Phys 1:116-119, 2000. 7. Maitz AH, Wu A: Treatment planning of stereotactic convergent gamma-ray irradiation using Co-60 sources. Med Dosim 23:169-175, 1998. 8. Maitz AH, Wu A, Lunsford LD, Flickinger JC, Kondziolka D, Bloomer WD: Quality assurance for gamma knife stereotactic radiosurgery. Int J Radiat Oncol Biol Phys 32:1465-1471, 1995. 9. Novotny J, Jr., Novotny J, Hobzova L, Simonova G, Liscak R, Vladyka V: Transportation dose and doses to extracranial sites during stereotactic radiosurgery with the Leksell Gamma knife. Stereotact Funct Neurosurg 66:170-183, 1996. 10. Regis J, Delsanti C, Roche PH, Thomassin JM, Pellet W:[Functional outcomes of radiosurgical treatment of vestibular schwannomas: 1000 successive cases and review of the literature]. Neurochirurgie 50:301-311, 2004. 11.Regis J, Hayashi M, Porcheron D, Delsanti C, Muracciole X, Peragut JC: Impact of the model C and Automatic Positioning System on gamma knife radio surgery: an evaluation in vestibular schwannomas. J Neurosurg 97:588-591., 2002. 12.Wu A, Lindner G, Maitz AH, Kalend AM, Lunsford LD, Flickinger JC, Bloomer WD: Physics of Gamma Knife approach on convergent beams in stereotactic radiosurgery. International Journal of Radiation Oncology, Biology, Physics 18:941-949, 1990. 13.Yu C, Luxton G, Apuzzo ML, MacPherson DM, Petrovich Z: Extracranial radiation doses in patients undergoing gamma knife radiosurgery. Neurosurgery 41:553-559; discussion 559-560, 1997. 13 018481.00 Oct. 2006.