SDX and radiotherapy ADVANTAGE OF DEEP INSPIRATION BREATH HOLD Research on the improvement of the quality of the radiotherapy of cancerous tumours that are influenced by breathing and diaphragm movements. Objectives of the SDX: FREE BREATHING A CT acquisition during a free breathing examination generates images of poor quality. It creates an uncertainty on the reconstructed gross tumour volume and dose distribution. The aim of this apparatus is the practise of a breath-hold method applied in all preparation and treatment phases. BREATH-HOLD METHOD IN DEEP INSPIRATION BREATH HELD So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 1/7
Materials and methods Patients receive thoracic radiotherapy with the benefit of this procedure. The breathing of the patient is measured with a spirometer. The patient is coached to reproduce a same level of breath-hold in deep inspiration. Video glasses help the patients to establish the breath-hold at the reference level. Preparing the treatment (scanner) The patient's breathing is measured with a spirometer connected to a disposable buccal nozzle. A nose-clip is used in order to avoid nasal breathing. Before the scan, we first establish the breathhold level that the patient can maintain effortlessly for 10 to 20 seconds. We here ask him to maintain his breath held, by inflating his lungs until we find the conditions for the best target volume positioning that suit him the best. During the scan, video glasses allow him to visualize his respiratory curves. When the technician asks him to hold his breath, he simply has to follow the yellow respiratory curve and place it in the red area. If the breath is held long enough, the technician tells him to go back to breathing normally. If the patient cannot maintain his breath held long enough, he just takes regular breaths for a minute, and then starts a new breath-hold. This procedure is then repeated at each session of the treatment. So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 2/7
Treatment (radiotherapy) During each session, even with a different staff, the irradiation can start only if the normal breathing measured during this session is the same as the reference one. Similarly, the rib cage position won t be different from the one first saved (same inspiration / expiration). The irradiation time is counted. The whole cycle is followed by the patient, wearing himself video glasses. On the video glasses screen, the patient see the level of normal breathing, as well as the target level of the lung expanding. Coloured bars are displayed to show these levels. The irradiation is triggered by the curve when it enters in the red reference area. It stops automatically when it leaves the reference area. Beforehand, the metabolic breathing must be in the reference green area. At this moment, the operator will activate a green light to inform the patient to start the exercise. This automation guarantees the reproducibility and the security of the treatment. So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 3/7
Results The patients follow the coaching during preparation and treatment without any difficulty. The better quality of the CT reconstructed images result in an easier contouring. No movements of the gross tumour volume lead to a better coverage. The deep breath hold decreases the volume of irradiated lung. Advantages This method increases the reproducibility of thoracic irradiation. The helical acquisition shows true images. No information loss about the initially moving volumes. Imaging is clearly improved. Contouring is easier. The lung volume is increased. The diaphragm slips out of inferior lobes and lets a very distinct place. Irradiation of healthy tissue is decreased. The modulated thoracic expansion allows the moving of the tumorous mass away from the healthy organs. Portal bronchial images are better. The decrease of irradiated lung volume offers prospects in dose escalation and intensity modulation radiotherapy. This technique applies to lung, but also to all the organs that move with the diaphragm. Key words: radiotherapy, lung cancer, inspiration and expiration breath-hold. The following French centers are equipped with this device: Centre François Baclesse in Caen, Centre Henry Becquerel in Rouen, Institut Bergonié in Bordeaux, Clinique Bordeaux Nord, Institut Curie in Paris, Centre René Gauducheau in Nantes, Centre Antoine Lacassagne in Nice, Centre Oscar Lambret in Lille, Hospices civils of Lyon, CHU Jean Minjoz in Besançon, CHU Pitié-Salpétriêre in Paris, CHU Georges Pompidou in Paris, Institut Claudius Regaud in Toulouse, Institut Gustave Roussy in Villejuif, CHU Saint André in Bordeaux, Institut Sainte Catherine in Avignon, CHU Saint Louis in Paris, CHU Strasbourg, Centre Val d Aurelle in Montpellier, Centre Alexis Vautrin in Nancy, C.H. Angoulême, C.H. Limoges, SAS Onco Azur Mougins, C.H. Mulhouse, Centre Eugène Marquis Rennes, Centre des Hautes Energies Toulouse, C.H. Carcassonne, C.H. Chambéry, SARL Therap X Paris Nord in Sarcelles, Royal Marsden in Londres, CH Montbéliard. So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 4/7
TECHNICAL DESCRIPTION PLUGGING ON THE PATIENT Sensor for lung s air volumes Flexible handling the lung s air volume sensor Mouthpiece and bacteria filter Nose clip Ballasted base containing measurement electronics Video glasses Waterproof cable of the Fleisch N 2 pneumotachograph heating 2 silicon pipes of the Fleisch N 2 pneumotachograph Volume sensor : Fleisch N 2 Base of pneumotachograph, heating cable s connector, and silicon pipes connectors Grip button of the Fleisch s support Disposable bacteria filter Video glasses for breathing display Disposable mouthpiece Nose clip So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 5/7
PLUGGING ON PERIPHERALS COMMAND ROOM Power supply 220V TREATMENT ROOM Power supply 220V Isolating power transformer 220V Patient's Environment : Dedicated multi-plug Spirometry sensor's support with filter and mouthpiece PC screen Computer Post USB cable SDX Power : 100-240V AC 50/60 Hz Video cable Glasses cable OPTION Command unit *Synchronization unit of the imaging or radiotherapy device Plan the crossing of the 2 cables between the rooms. Maximum cable's length: 20m. Alimentation :100/240 V AC 50/60Hz 9V DC Prise secteur 220V The connection of the command box can be and must be only done by a technical service approved by the radiotherapy or imaging device s manufacturer. *The SDX can work either connected to an imaging or a radiotherapy device, or independently of these devices. DEDICATED COMPUTER EQUIPMENT Laptop computer : Processor : Pentium 4 (or equivalent) and higher Operating system: Windows 2000, XP (Professional, Home), Vista 32(Premium, Professional). Memory: 512 Mo or higher Motherboard: 1 USB port available (USB 1.1 or 2). +1 for the Command unit option Video card: A screen connector available, with clone screen s management For a desktop computer the video card is Dual Head like, that is with 2 screen connectors and the clone screen s management. So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 6/7
TECHNICAL CARACTERISTICS OF SDX Power supply unit for sensor heating Input: Mains : 100-240V AC, 0.8A Frequency : 50/60 Hz Electronic board power Entrée: USB 5V DC, 0.5A SDX connections: 3 pins power cable AC CEI 320-C14 Input/output with USB 1.1 / 2 cable and connector to the PC. 20m USB/RJ45/USB extender cable Glasses: Input with 20m VGA cable for video screen Power 100/240V AC 0.8A 9V DC 3.3A Command unit option: Input USB cable 1.1 / 2 Output with cable and NO 2A contact (1 pair) connector to a radiotherapy device or scanner equipped with a synchronization card. OVERALL DIMENSIONS: 280 x 200 x 70 mm (box) 750 mm (arm + sensor) WEIGHT: 3300 g OPERATING SYSTEMS: Windows 2000/XP MEMORY: Memory size necessary by patient: 1Mo for each patient + preparing + 30 sessions PARAMETERS: Measured and stored in SpiroDyn'RX: Volumes: 12L ± 2% Time : 99s ± 0.01s MEASUREMENT SENSOR: Pneumotachograph 3 l/s ± 1% 280 mm 750 mm CE CONFORMITY: According to 93/42/CEE (medical directive) ISO EN 13485 2003 820 mm 70 mm CEM following IEC 60601-1-2 STANDARD INTERFACE: USB 1.1, USB 2 compatible SDX CONSISTS OF The complete measurement box The video glasses with power unit 10 nose clips Software on CD-ROM The installation manual 10 mouthpieces and bacteria filters 20m USB extender USB/RJ45/USB 20m VGA cable A 3L calibration syringe Option: Command unit Dyn R 73, rue de Louge BP 71 31603 MURET CEDEX T + 33 (0) 562 231 900 F + 33 (0) 562 231 901 www.dynr.com dynr@dynr.com So as to improve the product, the technical information can change with no advance notice SDX-V2.0 09 CIAL 03 A 7/7