# Patent

## Title
Method and system for evaluating quality assurance criteria in delivery of a treatment plan

## Abstract

System and method of evaluating quality assurance criteria related to the delivery of a radiation therapy treatment plan. The method includes the acts of acquiring image data of a patient, generating a treatment plan for the patient based at least in part on the image data, the treatment plan including a calculated radiation dose to be delivered to the patient, acquiring an on-line image of the patient in substantially a treatment position, delivering at least a portion of the calculated radiation dose to the patient, monitoring quality assurance criteria related to the delivery of the treatment plan, calculating the radiation dose received by the patient, and determining whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.

## Background
RELATED APPLICATIONS
This application claims priority to U.S. Provisional Patent Application No. 60/701,580, filed on Jul. 22, 2005, titled SYSTEM AND METHOD FOR FEEDBACK GUIDED QUALITY ASSURANCE AND ADAPTATIONS TO RADIATION THERAPY TREATMENT, the entire contents of which are incorporated herein by reference.


BACKGROUND
Over the past decades improvements in computers and networking, radiation therapy treatment planning software, and medical imaging modalities (CT, MRI, US, and PET) have been incorporated into radiation therapy practice. These improvements have led to the development of image guided radiation therapy (“IGRT”). IGRT is radiation therapy that uses cross-sectional images of the patient's internal anatomy to better target the radiation dose in the tumor while reducing the radiation exposure to healthy organs. The radiation dose delivered to the tumor is controlled with intensity modulated radiation therapy (“IMRT”), which involves changing the size, shape, and intensity of the radiation beam to conform to the size, shape, and location of the patient's tumor. IGRT and IMRT lead to improved control of the tumor while simultaneously reducing the potential for acute side effects due to irradiation of healthy tissue surrounding the tumor.
IMRT is becoming the standard of care in several countries. However, in many situations, IMRT is not used to treat a patient due to time, resources, and billing constraints. Daily images of the patient can be used to guarantee that the high gradients generated by IMRT plans are located on the correct position for patient treatment. Also these images can provide necessary information to adapt the plan online or offline if needed.
It is commonly known in the field of radiation therapy that there are many sources of uncertainty and change that can occur during a course of a patient's treatment. Some of these sources represent random errors, such as small differences in a patient's setup position each day. Other sources are attributable to physiological changes, which might occur if a patient's tumor regresses or the patient loses weight during therapy. A third possible category regards motion. Motion can potentially overlap with either of the other categories, as some motion might be more random and unpredictable, such as a patient coughing or passing gas, whereas other motion can be more regular, such as breathing motion, sometimes.
SUMMARY
In radiation therapy, uncertainties can affect the quality of a patient's treatment. For example, when delivering a treatment dose to a target region, it is standard practice to also treat a high-dose “margin” region about the target. This helps ensure that the target receives the desired dose, even if its location changes during the course of the treatment, or even during a single fraction. The less definite a target's location, the larger the margins that typically need to be used.
Adaptive radiation therapy generally refers to the concept of using feedback during the course of radiation therapy treatment to improve future treatments. Feedback can be used in off-line adaptive therapy processes and on-line adaptive therapy processes. Off-line adaptive therapy processes occur while the patient is not being treated, such as in between treatment fractions. In one version of this, during each fraction, a new CT image of the patient is acquired before or after each of the fractions. After the images are acquired from the first few treatment fractions, the images are evaluated to determine an effective envelope of the multi-day locations of target structures. A new plan can then be developed to better reflect the range of motion of the target structure, rather than using canonical assumptions of motion. A more complex version of off-line adaptive therapy is to recalculate the delivered dose after each fraction and accumulate these doses, potentially utilizing deformation techniques, during this accumulation to account for internal motion. The accumulated dose can then be compared to the planned dose, and if any discrepancies are noted, subsequent fractions can be modified to account for the changes.
On-line adaptive therapy processes typically occur while the patient is in the treatment room, and potentially, but not necessarily, during a treatment delivery. For example, some radiation therapy treatment systems are equipped with imaging systems, such as on-line CT or x-ray systems. These systems can be used prior to treatment to validate or adjust the patient's setup for the treatment delivery. The imaging systems may also be used to adapt the treatment during the actual treatment delivery. For example, an imaging system potentially can be used concurrently with treatment to modify the treatment delivery to reflect changes in patient anatomy.
One aspect of the present invention is to disclose new opportunities for the application of adaptive therapy techniques, and additional aspects are to present novel methods for adaptive therapy. In particular, adaptive therapy has typically focused on feedback to modify a patient's treatment, but the present invention focuses on adaptive therapy processes being used in a quality assurance context. This is particularly true in the context of whole-system verification.
For example, a detector can be used to collect information indicating how much treatment beam has passed through the patient, from which the magnitude of the treatment output can be determined as well as any radiation pattern that was used for the delivery. The benefit of this delivery verification process is that it enables the operator to detect errors in the machine delivery, such as an incorrect leaf pattern or machine output.
However, validating that the machine is functioning properly does not itself ensure proper delivery of a treatment plan, as one also needs to validate that the external inputs used to program the machine are effective and consistent. Thus, one aspect of the invention includes the broader concept of an adaptive-type feedback loop for improved quality assurance of the entire treatment process. In this aspect, the invention includes the steps of positioning the patient for treatment and using a method for image-guidance to determine the patient's position, repositioning the patient as necessary for treatment based upon the image-guidance, and beginning treatment. Then, either during or after treatment, recalculating the patient dose and incorporating the patient image information that had been collected before or during treatment. After completion of these steps, quality assurance data is collected to analyze the extent to which the delivery was not only performed as planned, but to validate that the planned delivery is reasonable in the context of the newly available data. In this regard, the concept of feedback is no longer being used to indicate changes to the treatment based on changes in the patient or delivery, but to validate the original delivery itself.
As an example, it is possible that a treatment plan might be developed for a patient, but that the image used for planning became corrupted, such as by applying an incorrect density calibration. In this case, the treatment plan will be based upon incorrect information, and might not deliver the correct dose to the patient. Yet, many quality assurance techniques will not detect this error because they will verify that the machine is operating as instructed, rather than checking whether the instructions to the machine are based on correct input information. Likewise, some adaptive therapy techniques could be applied to this delivery, but if the calibration problem of this example persisted, then the adapted treatments would suffer from similar flaws.
There are a number of processes that can be used to expand the use of feedback for quality assurance purposes. For example, in one embodiment, this process would include the delivery verification techniques described above. The validation of machine performance that these methods provide is a valuable component of a total-system quality assurance toolset. Moreover, the delivery verification processes can be expanded to analyze other system errors, such as deliveries based on images with a truncated field-of-view.
In one embodiment, the invention provides a method of system-level quality assurance. The method comprises the acts of acquiring image data of a patient, generating a treatment plan for the patient based at least in part on the image data, the treatment plan including a calculated radiation dose to be delivered to the patient, acquiring an on-line image of the patient in substantially a treatment position, delivering at least a portion of the calculated radiation dose to the patient, monitoring quality assurance criteria related to the delivery of the treatment plan, automatically calculating the radiation dose received by the patient, and determining whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.
In another embodiment, the invention provides a unified system for verifying delivering of a radiation therapy treatment plan to a patient. The system comprises a radiation therapy treatment device and a software program. The radiation therapy treatment device includes a computer processor and is operable to deliver radiation to a patient. The software program is stored in a computer readable medium accessible by the computer processor, and is operable to acquire image data of a patient, generate a treatment plan for the patient based at least in part on the image data, the treatment plan including a calculated radiation dose to be delivered to the patient, acquire an on-line image of the patient in substantially a treatment position, deliver at least a portion of the calculated radiation dose to the patient, monitor quality assurance criteria related to the delivery of the treatment plan, automatically calculate the radiation dose received by the patient, and determine whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.
In yet another embodiment, the invention provides a method of system-level quality assurance. The method comprises the acts of acquiring a first image of a patient, generating a treatment plan for the patient based at least in part on the image data, the treatment plan including a calculated radiation dose to be delivered to the patient, acquiring an on-line image of the patient in substantially a treatment position, generating a deformation map between the first image and the on-line image, delivering at least a portion of the calculated radiation dose to the patient, monitoring quality assurance criteria related to the delivery of the treatment plan, determining the radiation dose received by the patient based on the deformation map, and determining whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.
Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a radiation therapy treatment system.
FIG. 2 is a perspective view of a multi-leaf collimator that can be used in the radiation therapy treatment system illustrated in FIG. 1.
FIG. 3 is a schematic illustration of the radiation therapy treatment system of FIG. 1.
FIG. 4 is a schematic diagram of a software program used in the radiation therapy treatment system chart of a method of evaluating the delivery of a treatment plan according to one embodiment of the present invention.
FIG. 5 is a flow chart of a method of verifying system-level quality assurance according to one embodiment of the present invention.
FIG. 6 is a flow chart of a method of verifying system-level quality assurance according to one embodiment of the present invention.



DETAILED DESCRIPTION
Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
Although directional references, such as upper, lower, downward, upward, rearward, bottom, front, rear, etc., may be made herein in describing the drawings, these references are made relative to the drawings (as normally viewed) for convenience. These directions are not intended to be taken literally or limit the present invention in any form. In addition, terms such as “first”, “second”, and “third” are used herein for purposes of description and are not intended to indicate or imply relative importance or significance.
In addition, it should be understood that embodiments of the invention include both hardware, software, and electronic components or modules that, for purposes of discussion, may be illustrated and described as if the majority of the components were implemented solely in hardware. However, one of ordinary skill in the art, and based on a reading of this detailed description, would recognize that, in at least one embodiment, the electronic based aspects of the invention may be implemented in software. As such, it should be noted that a plurality of hardware and software based devices, as well as a plurality of different structural components may be utilized to implement the invention. Furthermore, and as described in subsequent paragraphs, the specific mechanical configurations illustrated in the drawings are intended to exemplify embodiments of the invention and that other alternative mechanical configurations are possible.
FIG. 1 illustrates a radiation therapy treatment system 10 that can provide radiation therapy to a patient 14. The radiation therapy treatment can include photon-based radiation therapy, brachytherapy, electron beam therapy, proton, neutron, or particle therapy, or other types of treatment therapy. The radiation therapy treatment system 10 includes a gantry 18. The gantry 18 can support a radiation module 22, which can include a radiation source 24 and a linear accelerator 26 operable to generate a beam 30 of radiation. Though the gantry 18 shown in the drawings is a ring gantry, i.e., it extends through a full 360° arc to create a complete ring or circle, other types of mounting arrangements may also be employed. For example, a non-ring-shaped gantry, such as a C-type, partial ring gantry, or robotic arm could be used. Any other framework capable of positioning the radiation module 22 at various rotational and/or axial positions relative to the patient 14 may also be employed. In addition, the radiation source 24 may travel in path that does not follow the shape of the gantry 18. For example, the radiation source 24 may travel in a non-circular path even though the illustrated gantry 18 is generally circular-shaped.
The radiation module 22 can also include a modulation device 34 operable to modify or modulate the radiation beam 30. The modulation device 34 provides the modulation of the radiation beam 30 and directs the radiation beam 30 toward the patient 14. Specifically, the radiation beam 34 is directed toward a portion of the patient. Broadly speaking, the portion may include the entire body, but is generally smaller than the entire body and can be defined by a two-dimensional area and/or a three-dimensional volume. A portion desired to receive the radiation, which may be referred to as a target 38 or target region, is an example of a region of interest. Another type of region of interest is a region at risk. If a portion includes a region at risk, the radiation beam is preferably diverted from the region at risk. The patient 14 may have more than one target region that needs to receive radiation therapy. Such modulation is sometimes referred to as intensity modulated radiation therapy (“IMRT”).
The modulation device 34 can include a collimation device 42 as illustrated in FIG. 2. The collimation device 42 includes a set of jaws 46 that define and adjust the size of an aperture 50 through which the radiation beam 30 may pass. The jaws 46 include an upper jaw 54 and a lower jaw 58. The upper jaw 54 and the lower jaw 58 are moveable to adjust the size of the aperture 50.
In one embodiment, and illustrated in FIG. 2, the modulation device 34 can comprise a multi-leaf collimator 62, which includes a plurality of interlaced leaves 66 operable to move from position to position, to provide intensity modulation. It is also noted that the leaves 66 can be moved to a position anywhere between a minimally and maximally-open position. The plurality of interlaced leaves 66 modulate the strength, size, and shape of the radiation beam 30 before the radiation beam 30 reaches the target 38 on the patient 14. Each of the leaves 66 is independently controlled by an actuator 70, such as a motor or an air valve so that the leaf 66 can open and close quickly to permit or block the passage of radiation. The actuators 70 can be controlled by a computer 74 and/or controller.
The radiation therapy treatment system 10 can also include a detector 78, e.g., a kilovoltage or a megavoltage detector, operable to receive the radiation beam 30. The linear accelerator 26 and the detector 78 can also operate as a computed tomography (CT) system to generate CT images of the patient 14. The linear accelerator 26 emits the radiation beam 30 toward the target 38 in the patient 14. The target 38 absorbs some of the radiation. The detector 78 detects or measures the amount of radiation absorbed by the target 38. The detector 78 collects the absorption data from different angles as the linear accelerator 26 rotates around and emits radiation toward the patient 14. The collected absorption data is transmitted to the computer 74 to process the absorption data and to generate images of the patient's body tissues and organs. The images can also illustrate bone, soft tissues, and blood vessels.
The CT images can be acquired with a radiation beam 30 that has a fan-shaped geometry, a multi-slice geometry or a cone-beam geometry. In addition, the CT images can be acquired with the linear accelerator 26 delivering megavoltage energies or kilovoltage energies. It is also noted that the acquired CT images can be registered with previously acquired CT images (from the radiation therapy treatment system 10 or other image acquisition devices, such as other CT scanners, MRI systems, and PET systems). For example, the previously acquired CT images for the patient 14 can include identified targets 38 made through a contouring process. The newly acquired CT images for the patient 14 can be registered with the previously acquired CT images to assist in identifying the targets 38 in the new CT images. The registration process can use rigid or deformable registration tools.
In some embodiments, the radiation therapy treatment system 10 can include an x-ray source and a CT image detector. The x-ray source and the CT image detector operate in a similar manner as the linear accelerator 26 and the detector 78 as described above to acquire image data. The image data is transmitted to the computer 74 where it is processed to generate images of the patient's body tissues and organs.
The radiation therapy treatment system 10 can also include a patient support, such as a couch 82 (illustrated in FIG. 1), which supports the patient 14. The couch 82 moves along at least one axis 84 in the x, y, or z directions. In other embodiments of the invention, the patient support can be a device that is adapted to support any portion of the patient's body. The patient support is not limited to having to support the entire patient's body. The system 10 also can include a drive system 86 operable to manipulate the position of the couch 82. The drive system 86 can be controlled by the computer 74.
The computer 74, illustrated in FIGS. 2 and 3, includes an operating system for running various software programs and/or a communications application. In particular, the computer 74 can include a software program(s) 90 that operates to communicate with the radiation therapy treatment system 10. The computer 74 can include any suitable input/output device adapted to be accessed by medical personnel. The computer 74 can include typical hardware such as a processor, I/O interfaces, and storage devices or memory. The computer 74 can also include input devices such as a keyboard and a mouse. The computer 74 can further include standard output devices, such as a monitor. In addition, the computer 74 can include peripherals, such as a printer and a scanner.
The computer 74 can be networked with other computers 74 and radiation therapy treatment systems 10. The other computers 74 may include additional and/or different computer programs and software and are not required to be identical to the computer 74, described herein. The computers 74 and radiation therapy treatment system 10 can communicate with a network 94. The computers 74 and radiation therapy treatment systems 10 can also communicate with a database(s) 98 and a server(s) 102. It is noted that the software program(s) 90 could also reside on the server(s) 102.
The network 94 can be built according to any networking technology or topology or combinations of technologies and topologies and can include multiple sub-networks. Connections between the computers and systems shown in FIG. 3 can be made through local area networks (“LANs”), wide area networks (“WANs”), public switched telephone networks (“PSTNs”), wireless networks, Intranets, the Internet, or any other suitable networks. In a hospital or medical care facility, communication between the computers and systems shown in FIG. 3 can be made through the Health Level Seven (“HL7”) protocol or other protocols with any version and/or other required protocol. HL7 is a standard protocol which specifies the implementation of interfaces between two computer applications (sender and receiver) from different vendors for electronic data exchange in health care environments. HL7 can allow health care institutions to exchange key sets of data from different application systems. Specifically, HL7 can define the data to be exchanged, the timing of the interchange, and the communication of errors to the application. The formats are generally generic in nature and can be configured to meet the needs of the applications involved.
Communication between the computers and systems shown in FIG. 3 can also occur through the Digital Imaging and Communications in Medicine (DICOM) protocol with any version and/or other required protocol. DICOM is an international communications standard developed by NEMA that defines the format used to transfer medical image-related data between different pieces of medical equipment. DICOM RT refers to the standards that are specific to radiation therapy data.
The two-way arrows in FIG. 3 generally represent two-way communication and information transfer between the network 94 and any one of the computers 74 and the systems 10 shown in FIG. 3. However, for some medical and computerized equipment, only one-way communication and information transfer may be necessary.
The software program 90 includes a plurality of modules that communicate with one another to perform functions of the radiation therapy treatment process. The various modules communication with one another to determine if delivery of the radiation therapy treatment plan occurred as intended.
The software program 90 includes a treatment plan module 106 operable to generate a treatment plan for the patient 14 based on data input to the system 10 by medical personnel. The data includes one or more images (e.g., planning images and/or pre-treatment images) of at least a portion of the patient 14. The treatment plan module 106 separates the treatment into a plurality of fractions and determines the radiation dose for each fraction or treatment based on the prescription input by medical personnel. The treatment plan module 106 also determines the radiation dose for the target 38 based on various contours drawn around the target 38. Multiple targets 38 may be present and included in the same treatment plan.
The software program 90 also includes a patient positioning module 110 operable to position and align the patient 14 with respect to the isocenter of the gantry 18 for a particular treatment fraction. While the patient is on the couch 82, the patient positioning module 110 acquires an image of the patient 14 and compares the current position of the patient 14 to the position of the patient in a reference image. The reference image can be a planning image, any pre-treatment image, or a combination of a planning image and a pre-treatment image. If the patient's position needs to be adjusted, the patient positioning module 110 provides instructions to the drive system 86 to move the couch 82 or the patient 14 can be manually moved to the new position. In one construction, the patient positioning module 110 can receive data from lasers positioned in the treatment room to provide patient position data with respect to the isocenter of the gantry 18. Based on the data from the lasers, the patient positioning module 110 provides instructions to the drive system 86, which moves the couch 82 to achieve proper alignment of the patient 14 with respect to the gantry 18. It is noted that devices and systems, other than lasers, can be used to provide data to the patient positioning module 110 to assist in the alignment process.
The patient positioning module 110 also is operable to detect and/or monitor patient motion during treatment. The patient positioning module 110 may communicate with and/or incorporate a motion detection system 112, such as x-ray, in-room CT, laser positioning devices, camera systems, spirometers, ultrasound, tensile measurements, chest bands, and the like. The patient motion can be irregular or unexpected, and does not need to follow a smooth or reproducible path.
The software program 90 also includes a treatment delivery module 114 operable to instruct the radiation therapy treatment system 10 to deliver the treatment plan to the patient 14 according to the treatment plan. The treatment delivery module 114 can generate and transmit instructions to the gantry 18, the linear accelerator 26, the modulation device 34, and the drive system 86 to deliver radiation to the patient 14. The instructions coordinate the necessary movements of the gantry 18, the modulation device 34, and the drive system 86 to deliver the radiation beam 30 to the proper target in the proper amount as specified in the treatment plan.
The treatment delivery module 114 also calculates the appropriate pattern, position, and intensity of the radiation beam 30 to be delivered, to match the prescription as specified by the treatment plan. The pattern of the radiation beam 30 is generated by the modulation device 34, and more particularly by movement of the plurality of leaves in the multi-leaf collimator. The treatment delivery module 114 can utilize canonical, predetermined or template leaf patterns to generate the appropriate pattern for the radiation beam 30 based on the treatment parameters. The treatment delivery module 114 can also include a library of patterns for typical cases that can be accessed in which to compare the present patient data to determine the pattern for the radiation beam 30.
The software program 90 also includes a feedback module 118 operable to receive data from the radiation therapy treatment system 10 during a patient treatment. The feedback module 118 can receive data from the radiation therapy treatment device and can include information related to patient transmission data, ion chamber data, MLC data, system temperatures, component speeds and/or positions, flow rates, etc. The feedback module 118 can also receive data related to the treatment parameters, amount of radiation dose the patient received, image data acquired during the treatment, and patient movement. In addition, the feedback module 118 can receive input data from a user and/or other sources. The feedback module 118 acquires and stores the data until needed for further processing.
The software program 90 also includes an analysis module 122 operable to analyze the data from the feedback module 118 to determine whether delivery of the treatment plan occurred as intended and to validate that the planned delivery is reasonable based on the newly-acquired data. The analysis module 122 can also determine, based on the received data and/or additional inputted data, whether a problem has occurred during delivery of the treatment plan. For example, the analysis module 122 can determine if the problem is related to an error of the radiation therapy treatment device 10, an anatomical error, such as patient movement, and/or a clinical error, such as a data input error. The analysis module 122 can detect errors in the radiation therapy treatment device 10 related to the couch 82, the device output, the gantry 18, the multi-leaf collimator 62, the patient setup, and timing errors between the components of the radiation therapy treatment device 10. For example, the analysis module 122 can determine if a couch replacement was performed during planning, if fixation devices were properly used and accounted for during planning, if position and speed is correct during treatment. The analysis module 122 can determine whether changes or variations occurred in the output parameters of the radiation therapy treatment device 10. With respect to the gantry 18, the analysis module 122 can determine if there are errors in the speed and positioning of the gantry 18. The analysis module 122 can receive data to determine if the multi-leaf collimator 62 is operating properly. For example, the analysis module 122 can determine if the leaves 66 move at the correct times, if any leaves 66 are stuck in place, if leaf timing is properly calibrated, and whether the leaf modulation pattern is correct for any given treatment plan. The analysis module 122 also can validate patient setup, orientation, and position for any given treatment plan. The analysis module 122 also can validate that the timing between the gantry 18, the couch 62, the linear accelerator 26, the leaves 66 are correct.
The analysis module 122 can also utilize deformable registration data to ensure that the patient 14 is receiving the correct radiation dose across multiple fractions. When analyzing the doses, it is useful to accumulate the dose across multiple treatment fractions to determine it any errors are being exacerbated or if they are mitigating each other. Registration is a method for determining the correlation between locations of a patient's anatomy or physiology across multiple images. Deformable registration is a method of determining the correlation between locations of a patient's anatomy or physiology to account for non-rigid changes in anatomy between the images, phases, or times. The radiation dose delivered to the patient 14 is recalculated based upon on-line images and feedback from the radiation therapy treatment device 10 to ensure that the correct dose has been or is being delivered to the patient 14.
The analysis module 122 also can utilize data related to deformation-based contouring of images for quality assurance purposes. Deformable registration techniques can be used to generate automatic or semi-automatic contours for new images. Generally, a contour set has been defined for planning or other baseline patient images, but with new images, a contour set is not usually readily available. Rather than require an operator to manually contour the image, it can be both faster and more consistent to perform a deformable image registration, and then use the deformation results as the basis for modifying the original contour set to reflect the new patient anatomy. A similar family of template-based contouring algorithms has been developed to generate contours for newly available images, based upon previously available sets of images and contours. These template-based algorithms might contour a new patient image based upon a previous patient image and contour, or potentially based upon a canonical or atlas patient image and contour. This can be performed for adaptive therapy as a means to accumulate doses in daily images, each with automatic daily contours. Moreover, whereas previously these algorithms were used in the context of generating new contours based upon canonical or atlas images, it is a new aspect of this invention to apply these techniques to the particular wealth of image data and types of images that arise during image-guided radiotherapy. Specifically, this includes deformation and template-based contouring of multiple images of the same patient in which contour sets might only exist for one of the images. These multiple images of the patient may arise from use of an on-line or in-room patient imaging system, with images potentially taken on different days, or these images might derive from a “4D” imaging system such as a CT scanner, in which each image represents a phase of motion, such as a breathing phase. It should also be noted that the on-line or in-room imaging system might be the same, a similar, or a different modality from the reference image. For example, the reference image might be a CT image, whereas the on-line image could be CT, cone-beam CT, megavoltage CT, MRI, ultrasound, or a different modality. By porting these contouring techniques to the applications of quality assurance and adaptive therapy, it is possible to both save a considerable amount of time from the contouring of images, and this method can also improve the consistency of contours across multiple images of the same patient (taken at different times or representing different phases). It is known that manual contours can suffer from irreproducibility, whereas automatically generated contours can potentially be more consistent in applying the principles of an initial contour to the generation of subsequent contours.
Another benefit of the contouring process using deformable registration techniques is that the contours generated can provide a validation of the deformation process. If the generated contours closely reflect contours that one would manually draw, then it is a good indication that the deformation process is reasonable; whereas if the automatic contours are less relevant, it indicates to the user that perhaps the deformation is inappropriate, but also provides the user an opportunity to verify the manual contours to check for mistakes or inconsistencies. Another aspect of this method is that the deformation-based contours can be used as a rough-draft of the contours for the adaptive process, and manually edited to reflect the desired contours for the on-line images. When doing this, the deformation process can then be re-run, constraining the deformation map to match the initial contours to the manually-edited automatic contours, and this helps direct consistent results through the rest of the image.
The analysis module 122 also is operable to utilize deformation maps to perform dose calculations on various images for quality assurance purposes. A deformation map can be utilized to relate a plurality of images where one image is a planning image that is useful for dose calculation, and another image, such as an on-line image, has qualitative value but less direct utility for dose calculation. This relation could then be used to “remap” the more quantitative image to the qualitative shape of the on-line or less quantitative image. The resulting remapped image would be more appropriate than either of the other two images for dose calculation or quantitative applications as it would have the quantitative benefits of the first image, but with the updated anatomical information as contained in the second image. This could be useful in a variety of cases, such as where the first image (e.g., a planning image) is a CT and where the additional image lacks quantitative image values (e.g., MRI, PET, SPECT, ultrasound, or non-quantitative CT, etc. images). A similar application of this method would be to correct for geometrical distortion, imperfections, and/or incompleteness in lieu of, or in addition to, quantitative limitations. For example, a current MRI image that well represents anatomy but includes geometric distortion might be remapped to a CT image that is not distorted. Or multiple images could be used to simultaneously correct for both distortion while representing anatomical changes.
As noted above, it is important to be able to recalculate dose on patient images acquired after the planning image. Given these doses, it is also useful to accumulate these doses for multiple delivered fractions. These doses can be added based upon the location of the doses in physical space, but a better method is to incorporate deformation methods into the process so as to add doses based upon the structures that received the dose, even if the structures have changed location. However, it is possible to build upon this technology to perform novel types of adaptive therapy.
In the context of recalculating doses, there are several other aspects of this invention to improve or facilitate this process. For example, after recording any daily registrations applied to the patient, potentially based upon image-guidance, these same registrations can optionally be applied to the patient images when recalculating dose. This can be performed automatically or semi-automatically. Alternately, the dose could be recalculated with a different registration. The benefit is that by automatically using the recorded registrations, the process of recalculating the doses that were delivered is simplified and streamlined. Moreover, by having the ability to recalculate doses for different registrations, one can experiment to determine if other patient alignment protocols might have been more or less effective. And by not using the recorded registration, one can determine how the treatment would have been affected in the absence of image guidance.
The dose recalculation process also can be enhanced by the padding of incomplete images. This is because a limited-size image, whether limited in the axial plane and/or in the superior/inferior direction, can degrade the accuracy of dose calculations. A method to overcome this is to pad the limited-size image with other image data, such as from the planning image. This padding method can work for both axially or superior/inferior limited data. In addition, another method for padding superior/inferior data is to repeat the end slices of the incomplete image as necessary until the data is sufficiently large for improved dose calculation.
Additional aspects of dose recalculation entail the calculation of dose to account for true 4D motion. Previous teachings describe methods for generating “4D CT” images, which are a time-based series of images or a collection of 3D image volumes that each represents a “phase” of a motion pattern, such as breathing. These images have been used for contouring, and even for generating treatment plans that anticipate a certain cycle of “phases”. However, patient breathing can often deviate from the ideally reproducible pattern indicated by a “4D CT” image set. The invention provides a method to recalculate dose more accurately on one of these volumes. This entails using a motion detection system 112 to monitor the patient's motion during treatment. This motion can be irregular or unexpected, and need not follow a smooth or reproducible trajectory. And the motion can be detected with any of a number of monitoring systems including x-ray, in-room CT, laser positioning devices, camera systems, spirometers, ultrasound, tensile measurements, or the like. Given these measurements, the dose can be recalculated for the patient's actual delivery by using the measured data to indicate the phase the patient was in at any given time, and recalculating the dose for each time in the phase of the 4D CT image best matching the patient's instantaneous position. This can also be performed using CT images collected simultaneously with patient treatment. In this latter case, phase identification might not be necessary. In one embodiment, deformation techniques would be used to accumulate doses between the different phases or images. In addition, the generation of updated 4D CT images before or during treatment could be used in conjunction with this method, as could other types of 4D images that are not strictly CT, such as 4D PET or 4D MRI, although these would typically require some modification to use these images quantitatively.
One application of this technology is to correct for poor treatments, such as what could result from poor planning, or poor delivery of a plan. The analysis module 122 can analyze the net dose delivered, and generate corrective plans to deliver the net desired dose or a dose chosen to match the intended biological effect. The original treatments would not need to be limited to photon-based radiation therapy, but could be any form of treatment including brachytherapy, electron beam therapy, proton, neutron, or particle therapy, or other types of treatments.
Another aspect of this invention is that the concept of adaptive therapy can be applied not only based upon the doses received alone, but also on predicted trends in the patient's treatment, clinical results, machine changes, and/or biological markers. For example, if a trend is detected in that a tumor is shrinking, or that a normal tissue structure is gradually migrating, the adaptive planning process could not only account for the current status of the patient and the doses delivered to date, but could also generate plans that reflect anticipated further changes in anatomy. Similarly, when analyzing cumulative dose information during the course of a treatment, the clinician can also consider the level of clinical effects and side-effects that the patient is experiencing, either based upon clinical findings or available biological markers or tests. If few side effects are felt, a more aggressive adaptive therapy treatment might be pursued, whereas if more complications are detected, the therapy might be modified to better avoid the effected region. Furthermore, plans can be adapted to compensate for detected changes in the machine, such as variations in output, energy, or calibration.
A variation of this theme is to perform a radiobiopsy. Early in a treatment, or before radiation treatment fully begins, the patient may receive a treatment fraction with a high radiation dose to a localized region, or potentially a dose only to a localized region. The effects on this region can be monitored to determine the nature of that region, such as whether it is tumorous, and what type. An appropriate course of treatment can be determined based upon these results, and the dose already delivered can be incorporated into the planning process.
FIG. 5 illustrates a flow chart of a method of verifying system-level quality assurance. Medical personnel acquire (at 200) an image of the patient and generate (at 204) a treatment plan for the patient 14 based on patient data, images, or other information. When the patient 14 is ready for a treatment, medical personnel position (at 208) the patient 14 on the couch 82 with the assistance of the patient positioning module 110 prior to delivery of treatment. Medical personnel initiate (at 212) acquisition of an on-line image of the patient 14 to assist in the positioning process. Additional positioning adjustments can be made as necessary. After the patient 14 is properly positioned, the user initiates (at 216) the treatment according to the treatment plan with the assistance of the treatment delivery module 114. During delivery of the treatment plan, the feedback module 118 acquires (at 220) data related to the radiation therapy treatment device 10 and patient parameters. During and/or after treatment, the analysis module 122 calculates (at 224) a radiation dose received by the patient 14 and determines (at 228) whether the delivery of the treatment plan occurred as intended.
FIG. 6 illustrates a flow chart of a method of verifying system-level quality assurance. Medical personnel acquire (at 250) an image of the patient and generate (at 254) a treatment plan for the patient 14 based on patient data, images, or other information. When the patient 14 is ready for a treatment, medical personnel position (at 258) the patient 14 on the couch 82 with the assistance of the patient positioning module 110 prior to delivery of treatment. Medical personnel initiate (at 262) acquisition of an on-line image of the patient 14 to assist in the positioning process. Additional positioning adjustments can be made as necessary. Medical personnel initiate (at 266) generation of a deformation map between one of the images in the treatment plan and the on-line image. After the patient 14 is properly positioned, the user initiates (at 270) the treatment according to the treatment plan with the assistance of the treatment delivery module 114. During delivery of the treatment plan, the feedback module 118 acquires (at 274) data related to the radiation therapy treatment device 10 and patient parameters. During and/or after treatment, the analysis module 122 calculates (at 278) a radiation dose received by the patient 14 and determines (at 282) whether the delivery of the treatment plan occurred as intended.
Various features and advantages of the invention are set forth in the following claims.

## Claims

1. A method of system-level quality assurance, the method comprising:
acquiring image data of a patient;
generating a treatment plan for the patient based at least in part on the image data, the treatment plan including a calculated radiation dose to be delivered to the patient;
acquiring an on-line CT image of the patient in substantially a treatment position;
delivering at least a portion of the calculated radiation dose to the patient;
monitoring quality assurance criteria related to the delivery of the treatment plan;
calculating the radiation dose received by the patient using the on-line CT image; and
determining whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.

2. A method as set forth in claim 1 wherein at least one of the steps is performed automatically.

3. A method as set forth in claim 1 wherein calculating the radiation dose includes radiation doses received during imaging.

4. A method as set forth in claim 1 and further comprising maintaining a database of common values and wherein the act of determining is based at least in part on the common values.

5. A method as set forth in claim 1 and further comprising generating a notification to stop the delivery of the treatment.

6. A method as set forth in claim 1 wherein monitoring quality assurance criteria includes using feedback data from the system used to deliver the treatment plan to determine whether delivery of the treatment plan occurred as intended.

7. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended includes identifying a problem occurring during delivery of the treatment plan.

8. A method as set forth in claim 7 wherein the problem is identified as a machine error.

9. A method as set forth in claim 7 wherein the problem is identified as an anatomical error.

10. A method as set forth in claim 7 wherein the problem is identified as a clinical error.

11. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended includes the use of deformable registration to accumulate data regarding the delivered dose.

12. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended includes the use of deformable registration to develop a contour of patient anatomy.

13. A method as set forth in claim 12 wherein deformable registration renders images amenable to dose calculation.

14. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended further comprises using recorded patient set up data or motion data.

15. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended is based on a combination of newly-acquired image data and pre-recorded image data.

16. A method as set forth in claim 15 wherein the newly-acquired image data and pre-recorded image data are merged to develop a composite image.

17. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended further comprises assessing other forms of treatment delivered and adjusting the treatment plan in response to the assessment.

18. A method as set forth in claim 1 and further comprising revising the treatment plan based on whether the delivery of the treatment plan occurred as intended and wherein the revision also accounts for predictive trends for any of the quality assurance criteria.

19. A method as set forth in claim 18 wherein revising the treatment plan further comprises generating predictive trends for at least a portion of the quality assurance criteria and evaluating the predictive trends.

20. A method as set forth in claim 19 wherein the predictive trends include predictive trends of clinical information.

21. A method as set forth in claim 1 and further comprising acquiring data relating to clinical dose delivered and patient effects, and applying a biological model that relates the clinical dose to the patient effect.

22. A method as set forth in claim 1 wherein calculating the radiation dose received by the patient includes an accumulated radiation dose received by the patient.

23. A method as set forth in claim 22 wherein calculating the radiation dose is performed automatically.

24. A method as set forth in claim 22 wherein the accumulated radiation dose is a combination of a scattered dose and an image dose.

25. A method as set forth in claim 1 and further comprising generating a notification for user error or treatment error.

26. A method as set forth in claim 25 and further comprising recalibrating the system components or parameter based upon the notification.

27. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended includes identifying whether the system requires service.

28. A method as set forth in claim 1 wherein determining whether delivery of the treatment plan occurred as intended includes identifying alternative treatments.

29. A unified system for verifying delivery of a radiation therapy treatment plan to a patient, the system comprising:
a radiation therapy treatment device including a computer processor, the radiation therapy treatment device operable to deliver radiation to a patient; and
a software program stored in a computer readable medium accessible by the computer processor, the software being operable to
acquire image data of a patient,
generate a treatment plan for the patient based at least in part on the image data,

the treatment plan including a calculated radiation dose to be delivered to the patient,
acquire an on-line CT image of the patient in substantially a treatment position,
deliver at least a portion of the calculated radiation dose to the patient,
monitor quality assurance criteria related to the delivery of the treatment plan,
calculate the radiation dose received by the patient using the on-line CT image, and
determine whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.

30. A system as set forth in claim 29 wherein the software program is operable to automatically perform at least one of the steps.

31. A system as set forth in claim 29 wherein the software program is further operable to identify a problem occurring during delivery of the treatment plan.

32. A method as set forth in claim 31 wherein the problem is identified as a machine error.

33. A method as set forth in claim 31 wherein the problem is identified as an anatomical error.

34. A method as set forth in claim 31 wherein the problem is identified as a clinical error.

35. A system as set forth in claim 29 wherein the software program is operable to acquire feedback data from the radiation therapy treatment device to determine whether delivery of the treatment plan occurred as intended.

36. A system as set forth in claim 29 wherein the software program is further operable to identify a problem occurring during delivery of the treatment plan and wherein the problem is related to one of a radiation therapy treatment device error, an anatomical error, and a clinical error.

37. A system as set forth in claim 29 wherein determining whether delivery of the treatment plan occurred as intended includes the use of deformable registration to accumulate data regarding the delivered dose.

38. A method of system-level quality assurance, the method comprising:
acquiring a first image of a patient;
generating a treatment plan for the patient based at least in part on the image data, the treatment plan including a calculated radiation dose to be delivered to the patient;
acquiring an on-line CT image of the patient in substantially a treatment position;
generating a deformation map between the first image and the on-line image;
delivering at least a portion of the calculated radiation dose to the patient;
monitoring quality assurance criteria related to the delivery of the treatment plan;
determining the radiation dose received by the patient using the on-line CT image and based on the deformation map; and
determining whether delivery of the treatment plan occurred as intended based on the quality assurance criteria and the radiation dose received by the patient.