Methods, Apparatuses, and Systems for Creating a Patient-Specific Soft Bolus for Radiotherapy Treatment
20200001112 ยท 2020-01-02
Inventors
- Tsuicheng D. Chiu (Plano, TX)
- Xuejun Gu (Dallas, TX)
- Jun Tan (Dallas, TX)
- Bo Zhao (Dallas, TX)
- Troy Long (Dallas, TX)
- Weiguo Lu (Dallas, TX)
- Tobin Strom (Dallas, TX)
- Kenneth Westover (Dallas, TX)
- Steve B. Jiang (Dallas, TX)
Cpc classification
B33Y80/00
PERFORMING OPERATIONS; TRANSPORTING
B29C33/3842
PERFORMING OPERATIONS; TRANSPORTING
A61N2005/1096
HUMAN NECESSITIES
International classification
Abstract
Methods, apparatuses, systems, and implementations for creating a patient-specific soft bolus for radiotherapy treatment are disclosed. 2D and/or 3D images of a desired radiotherapy treatment site may be acquired, such as the head, neck, skin, breast, anus, and/or vulva. A user may interact with one or more representations of the images via an interactive user interface such as a graphical user interface (GUI). The images may include target/avoidance structures and radiation beam arrangement. The user may interact with the images to create a visualization of a patient-specific bolus. The visualization and properties of the bolus may be modified as the user manipulates aspects of the image. Data corresponding to the bolus models may be used to create 3D printed negative molds of the bolus model using 3D printing technology. A soft patient-specific bolus may be cast using the 3D printed model.
Claims
1. A system for creating 3-dimensional (3D) representations of a bolus for radiotherapy treatment, the system comprising: a computer system comprising at least one processor configured to: receive at least one patient-specific radiation treatment planning parameter, wherein the at least one radiation treatment planning parameter comprises at least one image of a radiotherapy treatment area; enable an interaction between a user and the system, the interaction enabling a modification of the at least one radiation treatment planning parameter; enable a creation of at least one 3D patient-specific bolus model based on at least one dosimetric requirement, the at least one 3D patient-specific bolus model comprising a 3D representation of at least one patient-specific bolus for the radiotherapy treatment area; and enable the sending of 3D representation data corresponding to the at least one 3D patient-specific bolus model, the 3D representation data configured to enable a creation of at least one physical 3D representation of the at least one patient-specific bolus.
2. The system of claim 1, wherein the at least one radiation treatment planning parameter comprises one or more of a computed tomography (CT) scan image, one or more of a target and avoidance structure, one or more dosimetric prescriptions for the one or more of the target and avoidance structure, and a radiation beam arrangement.
3. The system of claim 1, where the computer system is further configured to: determine a type of beam treatment based on the at least one radiation treatment planning parameter; enable a creation of an initial 3D patient-specific bolus model based on the determined type of beam treatment; and enable a display of at least one radiation dose distribution on the initial 3D patient-specific bolus model.
4. The system of claim 3, where the type of beam treatment comprises one or more of photon beam treatment and electron beam treatment.
5. The system of claim 3, wherein the at least one dosimetric requirement is a user inputted dosimetric requirement.
6. The system of claim 3, where the at least one radiation dose distribution is configured to be interactively modified by the user.
7. The system of claim 3, where enabling an interaction between the user and the system comprises enabling the user to modify the at least one radiation dose distribution by performing one or more of morphing a dose distribution map and dragging the at least one radiation dose distribution to a different position, modifying a curvature of the at least one radiation dose distribution, and modifying a dimension of the at least one radiation dose distribution.
8. The system of claim 7, where the computer system is further configured to modify the at least one 3D patient-specific bolus model in real time to correspond to a user modification of the at least one radiation dose distribution.
9. The system of claim 1, where the computer system is further configured to: determine a type of beam treatment based on the at least one radiation treatment planning parameter; enable a creation of an initial 3D patient-specific bolus model based on the determined type of beam treatment; and enable an input of one or more of a physician dosimetric prescription on a target structure and at least one dosimetric constraint on an avoidance structure.
10. The system of claim 9, where the type of beam treatment comprises one or more of photon beam treatment and electron beam treatment.
11. The system of claim 9, where the one or more of a physician dosimetric prescription on a target structure and at least one dosimetric constraint on an avoidance structure is configured to be interactively modified by the user.
12. The system of claim 11, where the computer system is further configured to modify the at least one 3D patient-specific bolus model in real time to correspond to a user modification of the one or more of a physician dosimetric prescription on a target structure and at least one dosimetric constraint on an avoidance structure.
13. The system of claim 1, where enabling a creation of at least one physical 3D representation of the at least one patient-specific bolus comprises creating a 3D printed mold of the at least one patient-specific bolus, the 3D printed mold comprising a negative shape of the at least one patient-specific bolus.
14. The system of claim 13, where enabling a creation of at least one physical 3D representation of the at least one patient-specific bolus further comprises casting the at least one patient-specific bolus using the 3D printed mold.
15. The system of claim 14, where the at least one patient-specific bolus comprises a soft and flexible material such as a silicone-based material.
16. A method of creating 3-dimensional (3D) representations of a bolus for radiotherapy treatment, the method comprising: receiving, by a computer system comprising at least one processor, at least one patient-specific radiation treatment planning parameter, wherein the at least one radiation treatment planning parameter comprises at least one image of a radiotherapy treatment area; enabling, by the computer system, an interaction between a user and the system, the interaction enabling a modification of the at least one radiation treatment planning parameter; enabling, by the computer system, a creation of at least one 3D patient-specific bolus model based on at least one dosimetric requirement, the at least one 3D patient-specific bolus model comprising a 3D representation of at least one patient-specific bolus for the radiotherapy treatment area; and enabling, by the computer system, the sending of 3D representation data corresponding to the at least one 3D patient-specific bolus model, the 3D representation data configured to enable a creation of at least one physical 3D representation of the at least one patient-specific bolus.
17. The method of claim 16, wherein the at least one radiation treatment planning parameter comprises one or more of a computed tomography (CT) scan image, one or more of a target and avoidance structure, and a radiation beam arrangement.
18. The method of claim 16, further comprising: determining, by the computer system, a type of beam treatment based on the at least one radiation treatment planning parameter; enabling, by the computer system, a creation of an initial 3D patient-specific bolus model based on the determined type of beam treatment; and enabling, by the computer system, a display of at least one radiation dose distribution on the initial 3D patient-specific bolus model.
19. The method of claim 18, where the type of beam treatment comprises one or more of photon beam treatment and electron beam treatment.
20. The method of claim 18, wherein the at least one dosimetric requirement is a user inputted dosimetric requirement.
21. The method of claim 18, where the one or more radiation dose distribution is configured to be interactively modified by the user.
22. The method of claim 18, where enabling an interaction between the user and the system comprises enabling the user to modify the at least one radiation dose distribution by performing one or more of morphing a dose distribution map and dragging the at least one radiation dose distribution to a different position, modifying a curvature of the at least one radiation dose distribution, and modifying a dimension of the at least one radiation dose distribution.
23. The method of claim 22, further comprising modifying, by the computer system, the at least one 3D patient-specific bolus model in real time to correspond to a user modification of the at least one radiation dose distribution.
24. The method of claim 16, further comprising: determining, by the computer system, a type of beam treatment based on the at least one radiation treatment planning parameter; enabling, by the computer system, a creation of an initial 3D patient-specific bolus model based on the determined type of beam treatment; and enabling, by the computer system, an input of one or more of a physician dosimetric prescription on a target structure and at least one dosimetric constraint on an avoidance structure.
25. The method of claim 24, where the type of beam treatment comprises one or more of photon beam treatment and electron beam treatment.
26. The method of claim 24, where the one or more of a physician dosimetric prescription on a target structure and at least one dosimetric constraint on an avoidance structure is configured to be interactively modified by the user.
27. The method of claim 26, further comprising modifying, by the computer system, the at least one 3D patient-specific bolus model in real time to correspond to a user modification of the one or more of a physician dosimetric prescription on a target structure and at least one dosimetric constraint on an avoidance structure.
28. The method of claim 16, where enabling a creation of at least one physical 3D representation of the at least one patient-specific bolus comprises creating a 3D printed mold of the at least one patient-specific bolus, the 3D printed mold comprising a negative shape of the at least one patient-specific bolus.
29. The method of claim 28, where enabling a creation of at least one physical 3D representation of the at least one patient-specific bolus further comprises casting the at least one patient-specific bolus using the 3D printed mold.
30. The method of claim 29, where the at least one patient-specific bolus comprises a soft and flexible material such as a silicone-based material.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given method or system is not always labeled in every figure related to that method or system. Identical reference numbers do not necessarily indicate an identical feature. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers.
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0026] Tissue-equivalent boluses are often used in high-energy radiation therapy to compensate for surface irregularities on patients and to enhance radiation doses to the skin. Currently available boluses often consist of universal sheet-based gel polymer materials and are not ideal for many common clinical scenarios where the treated surface of a patient is irregular such as the head and neck, breast, fingers and toes, anus, and vulva. Recent developments in 3D printing technology provide solutions for designing patient-specific boluses. However, currently available methods for patient-specific bolus fabrication are cumbersome. The bolus design procedure is frequently a trial-and-error process, which is inefficient and a waste of clinical resources. Additionally, currently available manufactured boluses consist of a hard plastic material that is unacceptable to most patients because of discomfort. Hard plastic placed on existing tumor-associated or radiation-developed wounds can be extremely painful and difficult to tolerate for the patient.
[0027] This disclosure presents embodiments of an automatic and interactive bolus design processing interface that implements several processes for fabrication of dosimetric-driven patient-comfort-oriented soft boluses. The design platform may provide an easy solution for bolus design that results in a soft bolus that is far more tolerable for patients than other currently available solutions. In this way, the disclosed embodiments enable 1) automatic and interactive bolus design based on physician contoured structures and physician dosimetric prescription and 2) conversion of the bolus design to a physical soft bolus. Referring now to the drawings,
[0028] In some embodiments, 3D image application 108 may generate one or more 3D images of a bolus model. In some embodiments, the bolus model corresponds to a bolus for implementing the desired radiation treatment plan of the user. In some embodiments, the one or more 3D images may be converted to stereolithography (.stl) format and/or displayed as 3D orthographic images to enable orthographic views of the bolus model. The one or more 3D images may be displayed to a user and 3D image application 108 may enable a user to view and manipulate the one or more 3D images. In some embodiments, image manipulation capabilities may include capabilities to rotate, zoom, mark, color, and select the one or more images. In the embodiment shown, processing device 104 may be configured to send data corresponding to the one or more 3D images to a 3D printing device 112. 3D printing device 112 may create one or more 3D physical representations of the received one or more 3D images. In some embodiments, the one or more 3D physical representations may be a positive bolus mold and/or a negative bolus mold.
[0029]
[0030] In one embodiment of the disclosure, method 200 may be implemented by system 100. In the embodiment shown in
[0031] Method 200 may continue with bolus molding steps 204, 206, 208, 210. In some embodiments, the bolus is molded digitally. In some embodiments, the DICOM structure created in step 202 is exported and loaded into a bolus design interface 212. In some embodiments, the automatic/interactive bolus design interface may be a graphical user interface (GUI). In some embodiments, the automatic/interactive bolus design interface may be automatic and interactive bolus design application 106. In some embodiments, the automatic/interactive bolus design interface can be coded in MATLAB (Mathworks, USA). In step 204, the automatic/interactive bolus design interface may display one or more CT images from the patient DICOM along with treatment information such as radiation dose distribution map and/or radiation iso-dose lines. Based on the patient DICOM data, a bolus optimized to implement the treatment plan is automatically created. In step 206, a user may interact with the images in the interactive bolus design interface to modify the bolus design. In some embodiments, the user may modify the bolus shape by modifying or dragging one or more radiation iso-dose lines. In some embodiments, the user may modify the bolus shape by morphing radiation dose distribution.
[0032] In step 208, the automatic/interactive bolus design interface may take 2D discrete structure points from each slice of the image to create a raw 3D bolus mesh model. One or more smoothing algorithms or functions may be applied to the raw 3D bolus mesh model to create a smooth and more continuous model. In some embodiments, step 208 may comprise substeps 208a, 208b, and 208c. In step 208a, a closed bolus mold may be generated based on the smoothed 3D bolus mesh model. In step 208b, the closed bolus mold may be split into a positive mold and a negative mold and, in step 208c, the molds may be subjected to high gradient region repair. In some embodiments, 2 mm thick positive and negative mesh molds are created by digitally molding the smoothed 3D bolus model. In step 210, the smoothed 3D bolus model may be converted to .STL file format.
[0033] Method 200 may continue with bolus casting steps 214 and 216. In conventional system, the .STL file is usually sent to the 3D printer to fabricate the bolus directly. However, in some embodiments of the present method, the 3D printer is not used to fabricate the final product directly but is instead used to create accurate bolus molds that can then be used to cast silicone boluses. Exemplary 3D printers that can be used for implementing the present embodiments include the Makerbot Z18 and Makerbot Replicator Plus. Exemplary printing settings can be 3% filling, 0.3 mm layer height with bridges and supports as needed. Both of these exemplary printers have 11 micron positioning precision in X and Y (printing plate plane) directions and 2.5 micron in Z (elevational) direction. However, other suitable 3D printers and/or printing settings may be used.
[0034] In step 214, the 3D printer receives the .STL file of the smoothed 3D bolus model and prints the positive and/or negative molds of the bolus. In step 216, the 3D printed molds may be used to cast a patient-specific soft bolus. In some embodiments, a silicone material is used such as Smooth-on Ecoflex 00-30 (Smooth-on Inc., Macungie, Pa.) but other suitable silicone materials or other soft materials may be used. Cured silicone is a certified skin safe material that can minimize skin irritation and sensitization. Cured silicone is also very soft, very strong and very pliable. It may be stretched many times to its original size without tearing and can rebound to its original form without distortion. This silicone may be created using two parts of liquid compounds. After mixing up, the pot life may be about 45 minutes and may be cured in 4 hours. The curing process could be accelerated by adding a silicone cure accelerator to create the product in about 1.5 hours. Degassing the silicone liquid is important to achieve a high uniformity in the final product without air bubbles.
[0035] In some embodiments, after the positive and negative molds are printed and cleaned up, these two pieces are assembled together by using a hot glue gun to seal any possible leaking area. The degassed mixed silicone liquid is poured into the assembled mold. In some embodiments, a casting box may be used to support the molds during the casting process. Once the silicone is cured and hardens, the final product can be easily demolded and is ready for use. Depending upon the size (volume and surface area) and complexity, the process time may be varied.
[0036]
[0037]
[0038] In some embodiments, the interface may include two different bolus design modules: one for photon-beam treatment and one for electron-beam treatment. For photon-beam treatment, it is often a requirement that the bolus have a uniform, defined thickness. In this case, the bolus structure can be derived from the radiation target structure and beam arrangement of the TPS plan. The interface may automatically create a uniform bolus in the plane of the incident beams. For electron-beam treatment, a non-uniform bolus is used to modulate beams to achieve a desired radiation dose distribution. The interface may allow users to manually morph radiation dose distribution map and/or drag radiation iso-dose lines according to preference. In response, the interface may automatically revises the shape of the 3D bolus model shown in image field 410 accordingly.
[0039]
[0040] To print more complex bolus, the supporting materials are required for overhanging structures, ridges, bumps, and/or large curvature regions. This applies for almost every layer of fabricating with 3D printing technology. If supporting materials are presented inside the one-piece mold, it is a major challenge to clean up the supporting materials and achieve a clean surface at the same time without breaking up the mold. The mold will end up having a rough surface caused by residue of the supporting materials. This becomes a major limitation for a one-piece mold. Only a simple bolus that has a very gradual surface change could be fabricated by using a one-piece mold. On the contrary, printing positive and negative molds can resolve these issues. Even with the most complex bolus design, the supporting materials could be cleaned up easily with access to all the inner surfaces of the molds. This may reduce a lot of human work during the process of bolus shaping after the moldings are printed. With the embodiments of the interactive interface disclosed herein, one button click can generate a smooth 3D bolus mesh model and mold the model to create both positive and negative molds in .STL files.
[0041]
[0042] End to end tests were conducted on a head phantom (Model 038, Computerized Imaging Reference Systems, Inc. Norfolk, Va.). The bolus generation was simulated in Pinnacle based on old patient cases. Two bolus structures were made for disease sites near 1) the eye and 2) the left ear. Simplified plans were made: 1) AP/PA field at 6X on left ear site, and 2) AP field with 6e and 6 cm open cone on nose site. Optically Stimulated Luminescence Dosimeters (OSLDs) were placed to measure in-vivo doses on the phantom. The OSLDs (nanoDot, Landauer, Glenwood, Ill.) came pre-calibrated and had an accuracy of 5%. Kilo-voltage (kV) images were acquired to determine the actual location of OSLDs on the phantom surface in order to determine the planning doses.
[0043] Several patients were treated using the custom silicone bolus. The dose distribution was compared between initial simulation CT with virtual bolus design and rescan CT with the actual bolus. In-vivo doses were measured with OSLDs. Typically, two OSLDs were placed for each patient to get an average result. Locations of the OSLDs were in the middle of the light field or generally at center of crosshair on patient skin. Finally, efficiency on the material cost and time was estimated.
[0044]
[0045] Listed in Table 1 below is the Hounsfield unit (HU) of various bolus materials together with their physical densities. The CT number generally increases with physical density except for SuperFlab which may be due to a CT partial volume effect from the limited thickness of the material. The standard deviations are small and at a similar level for these materials, indicating good uniformity.
TABLE-US-00001 TABLE 1 CT properties of soft bolus material Material CT number Density(g/cm3) Silicone rubber 139.5 6.4 1.07 Water 3.1 3.3 1.00 SuperFlab 4.7 5.4 1.02 Solid water 11.2 7.3 1.04
[0046]
[0047]
TABLE-US-00002 TABLE 2 In-vivo dose measurements on phantom and information on patient cases Bolus OSLD Treatment volume reading Patient Age Disease Site (cc) Rx (cGy) Phantom N/A N/A nose 55.8 9e, 190.7 200cGyx2 5 to 90% Phantom N/A N/A Lt ear 166.7 6X, 199.7 200cGyx25, AP/PA 1 70 skin Lt Ear 557 6X, 198.1 cancer 200cGyx25, wedged pair 2 77 head and Lt cheek 230 9 MeV, 220.2 neck 200cGyx 30 angio- to 86% sarcoma 3 68 Basal cell Nasal 180 18e, 68Gy in 196.9 carcinoma cavity 34 fx to 95% of skin of nose 4 70 Basal cell Nose 499 18e, 189.8 carcinoma 200cGyx8 to of skin 90% 5 68 subcu- cheek and 98 9e, 12e, 302.4 taneous, nose 300cGyx15 and other soft tissues of head, face and neck
[0048] The embodiments described herein achieve multiple advantaged over commercially available custom boluses that have been applied in radiation treatment. Because of the nature of hard material, hard boluses inevitably introduces some gaps. They also do not provide for patient comfort especially if the patient has an open wound and they are not easily modified once made. In-vivo measurements with this bolus are not easy because they further generate gaps between the bolus and the skin surface. A 3D printed bolus may be economic and time efficient compared with the commercial hard bolus but it has similar disadvantages of a hard surface even for semi-elastic materials. In addition, a bolus printed by a commercial 3D printer usually prints with 100% fill. This adds a long printing time especially for a large bolus used as a compensator in photon beam radiation. Inhomogeneity associated with an FDM printed bolus may also impact the use in proton therapy and electron therapy.
[0049] Compared with hard plastic boluses, soft boluses are skin friendly. Commercially available SuperFlab blouses have been used in radiation therapy clinics for decades. They are reusable and can be used for multiple patients. However, they do not conform well to the patient's skin for regions such as head and neck, scalp, or breast. Other types of bolus materials are not easily shaped to match a desired shape shown in TPS. The custom soft bolus described herein conforms to a patient's skin very well as in-vivo measurements have proved. A summary of cost and effectiveness of different boluses are listed in Table 3. Among them, a soft custom bolus provides the best clinical effectiveness and patient comfort with a reasonable cost.
TABLE-US-00003 TABLE 3 Comparison of custom boluses 3D printed Commercial Soft Commercial bolus (100% reusable soft custom Bolus type custom bolus fill) bolus bolus Material cost *** ** * ** Time cost *** ** none * Clinical ** ** * *** effectiveness Patient ** ** *** *** comfort
[0050]
[0051] For conventional radiation therapy, the preparation for the treatment under current clinical practice takes about one week from the simulation to the first treatment broken down as follows: Day 1CT simulation, Day 2 to 4contouring and planning, Day 3 to 5quality assurance checks and Day 6 to 8initial treatment. Depending upon the size and complexity of the desired boluses, the turnaround for manufacturing a silicone bolus using the disclosed embodiments is about 1 to 3 days. Once the bolus structure is ready at Day 2 to 4, the requested boluses could be ready in a quality assurance checking time frame (around Day 3 to 6).
[0052] Therefore, the disclosed methods, apparatuses, and systems improve clinical efficiency by using automatic/interactive bolus design interfaces that avoid time-consuming trial-and-error methods; improve dosimetric accuracy for treatment planning by minimizing the air gaps between the bolus and the patient, reducing treatment dose uncertainty and improving radiation coverage; improve dosimetric accuracy for treatment re-planning by providing the ability to rapidly recreate patient-specific boluses during radiotherapy treatment courses as the tumor and/or surface changes; and improve patient comfort because the soft bolus material makes the bolus more comfortable than previously reported 3D bolus concepts that use hard materials.
[0053] It may be appreciated that the functions described above may be performed by multiple types of software applications, such as web applications or mobile device applications. If implemented in firmware and/or software, the functions described above may be stored as one or more instructions or code on a non-transitory computer-readable medium. Examples include non-transitory computer-readable media encoded with a data structure and non-transitory computer-readable media encoded with a computer program. Non-transitory computer-readable media includes physical computer storage media. A physical storage medium may be any available medium that can be accessed by a computer. By way of example, and not limitation, such non-transitory computer-readable media can comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other physical medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. Disk and disc includes compact discs (CD), laser discs, optical discs, digital versatile discs (DVD), floppy disks and Blu-ray discs. Generally, disks reproduce data magnetically, and discs reproduce data optically. Combinations of the above are also included within the scope of non-transitory computer-readable media. Moreover, the functions described above may be achieved through dedicated devices rather than software, such as a hardware circuit comprising custom very large scale integrated (VLSI) circuits or gate arrays, off-the-shelf semiconductors such as logic chips, transistors, or other discrete components, all of which are non-transitory. Additional examples include programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices or the like, all of which are non-transitory. Still further examples include application specific integrated circuits (ASIC) or VLSI circuits. In fact, persons of ordinary skill in the art may utilize any number of suitable structures capable of executing logical operations according to the described embodiments.
[0054] The above specification and examples provide a complete description of the structure and use of illustrative embodiments. Although certain embodiments have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. As such, the various illustrative embodiments of the disclosed methods, devices, and systems are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and embodiments other than those shown may include some or all of the features of the depicted embodiment. For example, components may be combined as a unitary structure and/or connections may be substituted. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments.
[0055] The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) means for or step for, respectively.