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Tipton KN, Sullivan N, Bruening W, et al. Stereotactic Body Radiation Therapy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 May. (Comparative Effectiveness Technical Briefs, No. 6.)

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Stereotactic Body Radiation Therapy [Internet].

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Appendix FCurrently Marketed Devices for SBRT

Devices Currently Marketed for Stereotactic Body Radiation Therapy

Device NameManufacturer/DistributorFeaturesDedicated to SRSFDA IndicationExtracranial Indications Presented on Company Web site
AxesseElekta

Beam delivery – wide range of noncoplanar angles

Beam energy – multiple energy (photon)

Collimation – MLC

Design – image-guided robotic linac that combines high-conformance beam shaping with 4D Adaptive™ IGRT technology

Dose delivery – multiple energy choices

Imaging – CT/MR imaging with patient in immobilization (no fiducials necessary)

Patient Positioning/Localization – BodyFIX dual vacuum-activated immobilization and fixation system; automatic reposition in up to 6 degrees of freedom

Treatment Sessions – single and fractionated

NoNo response from FDA or manufacturerSpinal metastases, lung, liver, prostate, head, neck
CyberKnife® robotic radiosurgery systemAccuray Incorporated

Beam delivery – noncoplanar and nonisocentric; anterior beam delivery

Beam energy – 6 MV nominal (photon)

Collimation – 12 fixed apertures; Xchange™ Robotic Collimator Changer automatically exchanges collimators

Design – a treatment radiation generator, linear accelerator, manipulator (robot) with six degrees of freedom, and a target locating subsystem

Dose delivery – A 6 MV X-band linac

Field size – determined by the use of interchangeable secondary circular cones with diameters ranging from 5.0 to 60.0 mm

Imaging – continuously delivers imaging to ensure target accuracy throughout the entire treatment; InTempo™ Adaptive Imaging System tracks and corrects for intra-fraction prostate motion

Output – available at 800 MU/min at 80 cm, 600 MU/min, and 400 Mu/min

Patient Positioning/Localization – only radiosurgery system to move to and with the patient; room-based stereo x-ray with 2D kV-kV match

Tracking – Fiducial tracking, Xsight™ Spine Tracking, Xsight™ Lung Tracking, and Synchrony™ Respiratory Tracking for dynamic positioning and pointing of the linac

Treatment Sessions – single and fractionated

YesTreatment planning and image-guided SRS and precision RT for lesions, tumors and conditions anywhere in the bodySpine, lung, liver, prostate, pancreas, kidney, head, neck
Leksell Gamma Knife® PerfexionElekta Inc.

Beam delivery – 192 cobalt-60 sources housed in the central body of the unit produce 192 collimated beams directed to a single focal point (isocenter)

Collimation – 4,8, 16 mm diameter

Design – a radiation unit with patient-positioning system and an operator console

Dose delivery – multiple converging fixed beams of ionizing radiation

Imaging – MRI/CT prior to treatment

Output – >3 Gy/min

Patient Fixation – head fixated in the Leksell® Stereotactic Frame. Awaiting approval on re-locatable frame.

Total cobalt-60 activity at loading (approximate) – <6,300 Curie (2.33 × 1014 Bq)

Treatment Sessions – single with availability of fractionated upon approval of Extend™ program

NoMetastatic tumors, and head structure targets (a few millimeters to several centimeters)Cervical spine, head, neck, larynx tumors
MHI-TM2000 Linear Accelerator SystemMitsubishi Heavy Industries (MHI)

Beam delivery – Gimballed x-ray irradiation offers tilt and pan-rotation functions enabling fine adjustments in any direction

Collimation – MLC

Design – O-ring-shaped mechanical structure provides a high level of rigidity; X-ray generator incorporates a compact accelerator tube

Image Processing System – ExacTrac 3rd Party by BrainLAB (K072046 approved by FDA on 8/07)

Treatment Sessions – single and fractionated

NoRadiation therapy of lesions, tumors and conditions anywhere in the bodyNR
Novalis TXBrainLAB/Varian Medical Systems

Accuracy - millimeter precision utilizing BrainLAB’s iPlan and ExacTrac technologies

Beam delivery – fixed beam positions and continuous arc delivery with RapidArc; anterior beam delivery and full 180 degree posterior beams

Beam energy – 6–20 MV/6–20MEV

Collimation –Varian’s HD120 MLC 120 interleaved ultra thin collimators provides 2.5 mm collimation at isocenter and 5.0 mm collimations at the periphery.

Design – includes Adaptive Gating and On-Board Imager devices

Field size – 22 × 40 cm maximum

Imaging – ExacTrac and x-ray 6D and Snap Verification

Output – 1,000 MU at 100 cm

Patient positioning/localization – 6D Robotic couch top, Varian Exact® couch

Treatment Sessions – single and fractionated

YesThe Varian High Energy linear accelerator is intended to provide SRS and precision RT for lesions, tumors and conditions anywhere in the bodySpine, lung, liver, prostate, head, neck
Oncor ARTISTE, Impression, Avant-Garde, ExpressionSiemensArtiste

Beam energy – 6 MV (photon)

Collimation – 160 leaf MLC

Design – includes an Electronic Portal Imaging Device (EPID), a 160 leaf MLC, and the syngo™ RT Therapist Express Workspace with MVision™

Imaging – OPTIVUE 1000ART amorphous silicon (a-Si) portal imaging system

Patient-positioning verification – use of the OPTIVUE imaging system, including MVision™ Megavoltage Cone Beam (MVCB) Imaging and/or CTVision

Respiratory Gating – ANZAI breathing belt system

Impression/Avant-Garde/Expression

Beam energy – 6/10 MV photon/6–21 MeV

Collimation – OPTIFOCUS 82 leaf MLC (static and dynamic modes)

Field size – 40 cm × 40 cm fully-conformal

Imaging OPTIVUE 1000/ST electronic portal imaging device (EPID) and MVision™ megavoltage cone beam on-board imaging

Output – 200–500 MU/min, special configuration-1,000 MU/min for maximum 5 × 5 cm field (Avant-Garde); 200–300 MU/min, special configuration-500 MU/min for maximum 5 ×5 field

Patient position localization and setup – Adaptive Targeting™ supports alignment of 3D planning data with newly acquired 3D Cone Beam data

Respiratory Gating – standard on Avant-Garde/optional on Impression

NoThe delivery of x-ray radiation for therapeutic treatment of cancer.Head, neck, extracranial areas
Synergy®SElekta Inc.

Beam delivery – a 62 cm treatment head in combination with industry best isocenter clearance allows for a wide variety of treatment approaches including noncoplanar

Beam energy – 4, 6, 10, 15, 18, and 25 MV photon; 6, 9, 12, 15, 18, and 25 MeV

Collimation – Beam Modulator, an integrated high-resolution, multi-leaf collimator designed for extracranial SRS

Dose delivery system – includes an integrated multi-leaf collimator

Field size – 16 cm × 21 cm

Imaging – 4D Adaptive™ IGRT technology

Patient positioning/localization – BodyFix® and HeadFix® immobilization accessories

Treatment Sessions – single and fractionated

NoRadiation therapy treatment of malignant neoplastic diseasesSpine, lung, liver, prostate, pancreas, head, neck
TomoTherapy®
Hi-Art®
TomoTherapy Inc.

Accuracy – beam modulating technology that divides a single beam into “beamlets” to better conform to tumors

Beam delivery – 360 degree

Beam energy – 6 MV (photon)

Collimation – 64 leaf MLC

Design – linac mounted to a CT scanner-like ring gantry

Field size – 40 cm × 1.6 meters maximum

Imaging – integrated, 3D daily CTrue™ imaging

Output – 850 cGy/min (photon)*

Patient positioning/localization – AlignRT® (consisting of 2 ceiling- mounted 3D camera units) registers real-time image data and subsequently updates couch coordinates. Complements CTrue™ imaging when tumor is deep-seated or can move internally w/o external evidence

Treatment Sessions – single and fractionated

NoTo tumors or other targeted tissuesLung, liver, prostate, head, neck
Trilogy™Varian Medical Systems

Accuracy – beam modulating technology that divides a single beam into “beamlets” to better conform to tumors

Beam delivery – choice of Intensity modulated radiosurgery (IM-RS) with multi-leaf collimation – for lesions >2.5 cm, irregular shaped and >3 lesions OR Cone-based SRS for lesions <2.5 cm, not irregular and 1–3 lesions

Beam energy – 6 MV (photon)/4–22 MeV (6 energies)

Collimation – 120 leaf MLC and conical collimator

Design – external system gating interface, remote couch motion

Field size – 15 cm × 15 cm

Imaging – PortalVision MV imager, On-Board kV Imager (amorphous silicon detector-based radiographic, fluoro and cone-beam CT).

Output – 1,000 MU/min (photon and electron)

Patient position/localization – optional optical imaging-based patient positioning (FrameArray, BodyArray, and SonArray)

Respiratory Gating – Real-time Position Management™ (RPM) System

Treatment Sessions – single and fractionated

NoLesions, tumors and conditions anywhere in the bodyWhole body
*

Data derived from548

AVM: Arteriovenous malformation

Bq: Becquerel

cGY/min: Centigray per minute

cm: Centimeter

CT/MR: Computed tomography/magnetic resonance

FDA: United States Food and Drug Administration

IGRT: Image guided radiation therapy

kV: Kilovolt

Linac: Linear accelerator

MEV: Million electron volt

MLC: Multi-leaf collimator

mm: Millimeter

MU/min: Monitor units per minute

MV: Megavolt

NR: Not reported

RS: Radiosurgery

RT: Radiotherapy

SRS: Stereotactic radiosurgery

SRT: Stereotactic radiotherapy

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