This invention relates generally to the medical field, and more specifically to an improved method of characterizing the pathological response of tissue to a treatment plan in the cancer treatment field.
Common treatments for cancer include removal of cancerous tumor tissue from the patient, radiation treatment, chemotherapy, or ablation interventions, but the most effective treatment or combinations of treatments typically varies from patient to patient. For example, not all cancer patients respond to certain treatments like chemotherapy and radiation treatment, and furthermore not all responsive cancer patients have equal success with these treatments. The success of a treatment for a patient is often not known until the end of the treatment or after a follow-up period after the treatment. However, it is advantageous to be able to accurately predict whether a patient will respond well to a treatment, particularly earlier in the treatment plan, to guide implementation of alternative regimens and/or to abort an unsuccessful treatment plan. Accurate and frequent evaluation of a tumor's response to treatment allows a physician to optimize the treatment plan for the patient, and potentially spare an unresponsive patient from unnecessary side effects from the treatment, such as the physical and emotional toll of chemotherapy-induced side effects. Monitoring the state of tumor tissue in a patient could theoretically be performed with repeated use of magnetic resonance imaging (MRI) or positron emission tomography (PET). However, these technologies are costly and may not be accessible in a community for repeated use, making them ill-suited for frequent evaluation of tumor tissue. Other technologies, such as X-rays, utilize ionizing radiation that precludes frequent use. Thus, there is a need in the medical field to create an improved method of characterizing the pathological response of tissue to a treatment plan. This invention provides such an improved method.
The following description of preferred embodiments of the invention is not intended to limit the invention to these preferred embodiments, but rather to enable any person skilled in the art to make and use this invention.
As shown in
The step of obtaining a set of sequential morphology renderings S110 functions to obtain data from the patient. This data forms the basis of analysis in characterizing the response of the tissue to a cancer treatment. The morphology renderings preferably include renderings of tumor tissue, and may additionally and/or alternatively include renderings of healthy tissue such as that surrounding the tumor tissue. The morphology renderings may additionally and/or alternatively broken bones or any suitable tissue. Each rendering preferably corresponds to a particular point in time during the treatment plan, such that the set of renderings represent sequential, chronological snapshots of the tissue at various points in time during the treatment plan. For example, obtaining a rendering may be performed hourly, daily, every few days, every 1-3 weeks, or any suitable frequency, or performed in correspondence (e.g., immediately before and/or immediately after) a treatment phase such as a chemotherapy treatment. Obtaining a set of renderings S110 is preferably performed in early stages of a treatment plan (e.g., within the first several months), but may alternatively be performed during any suitable portion of the treatment plan. The set of renderings may be taken at approximately regular time intervals during the treatment plan, or at irregular time intervals (for example, the timing of the renderings may depend on particular scheduling of chemotherapy treatments). In a preferred embodiment, obtaining a set of renderings S110 preferably includes scanning the tissue with an ultrasound scanner to obtain acoustic data S112 and creating images representing acoustic parameters of the tissue with the acoustic data S114. The steps of scanning the tissue and creating images are each preferably performed at least once each time a single rendering is obtained, such that the steps of scanning the tissue and creating images are repeated multiple times. Obtaining a set of renderings S110 may additionally and/or alternatively include retrieving a set of images or renderings from a storage device such as a hard drive or an online server, or any suitable storage such as hard copy patient records.
The step of scanning the tissue S112 preferably includes surrounding the tissue with a transducer that transmits and receives acoustic waves through the tissue. For example, as shown in
The step of creating images representing acoustic parameters of the tissue S114 preferably includes generating one or more two-dimensional (2D) images from the acoustic data obtained during the scanning step, and may include generating one or more three-dimensional (3D) images of the tissue. In a preferred embodiment, as shown in
The step of generating a set of representative values of a biomechanical property S120 functions to quantify or otherwise characterize the biomechanical property in the set of renderings. As shown in
In one variation, the average value may be the mean or other statistical average of multiple volume averages of the multiple tumors, or the maximum volume average value of the multiple volume averages of multiple tumors. In another variation, the average value is the mean or other statistical average of any suitable healthy or unhealthy portion of the rendered tissue. However, the average value may alternatively be any suitable average value.
Calculating an average value of the biomechanical property for each rendering S122 preferably includes accounting for the difference between the value of the biomechanical property within the tumor tissue and the value of the biomechanical property in background tissue surrounding the tumor tissue S124. Accounting for the difference functions to disregard the value of the biomechanical property in the background tissue. Preferably, accounting for the difference S124 includes subtracting an average value of the biomechanical property in background tissue from the volume average value of the biomechanical property of the tumor tissue S126, but the difference may be accounted for in any suitable manner. The boundary of background tissue relative to tumor tissue in each rendering may be defined in one or more of several manners. In one variation, the background tissue may be defined as a region beyond a distance threshold (e.g., 2 centimeters) beyond the boundary of the outlined tumor tissue. In another variation, the background tissue may be defined as a region beyond a boundary where the gradient in the biomechanical property satisfies a difference threshold. However, the boundary of background tissue relative to tumor tissue may be defined in any suitable manner.
In another variation, generating a set of representative values S120 includes determining an initial or baseline value of the biomechanical property, or any suitable singular value of the biomechanical property. For instance, the initial value may be taken from the first rendering obtained in step S110. Furthermore, determining a trend of the biomechanical property S130 may include characterizing initial values of multiple biomechanical properties, or any suitable singular values of multiple biomechanical properties.
Alternatively, generating a set of representative values S120 may include characterizing the spatial distribution of the biomechanical property in each of the set of renderings. The characterization may be qualitative, or may be quantitative such as by generating a parameter descriptive of the spatial distribution of the biomechanical property. Generating a set of representative values S120 may include characterizing the spatial distribution of acoustic speed in an acoustic rendering, but may additionally and/or alternatively include characterizing the spatial distribution of acoustic attenuation or any suitable biomechanical property.
The step of determining a trend of the biomechanical property S130 functions to generate metrics, based on the acoustic data, that may be analyzed for predicting or otherwise characterizing patient response to a treatment plan. Determining a trend S130 preferably includes calculating a rate of change in the set of average values S132, which may be one or more of several variations. In a first variation, as shown in
In a second variation, determining a trend of the biomechanical property S130 includes mathematically calculating the rate of change. The calculation may be similar to the first variation except the computation is performed without graphing the set of average values on a plot.
In a third variation, determining a trend of the biomechanical property S130 includes determining a trend of multiple biomechanical properties. For example, initial values of multiple biomechanical properties may be characterized relative to each other, such as by plotting (or comparing in any suitable manner, such as by calculating a ratio) the initial value of one biomechanical property against another biomechanical property. For example, in determining a trend of multiple biomechanical properties, the initial value of acoustic speed of the tissue may be compared to the initial value of acoustic attenuation of the tissue. Furthermore, as shown in
In an alternative embodiment, determining a trend of the biomechanical property S132 may include graphing the set of average values of the biomechanical property on a plot against a temporal variable, similar to the plot of the first variation, and characterizing the general shape of the curve formed by the plot. The general shape (e.g., a plateau) of the curve may be characterized quantitatively and/or qualitatively. For example, the trend of the biomechanical property shown on the plot may be described as having a certain type of slope or plateau indicating an approximately degree of gradient or flatness, respectively.
The step of predicting response of the tissue S140 based on the trend of the biomechanical property functions to characterize the tissue response to the treatment plan. During the predicting step, the trend of the biomechanical property may be assessed for change in tissue properties, such as for long-term multiple stage intervention like chemotherapy and radiation therapy, or for cell death as a result of ablation interventions like cryotherapy, radiofrequency (RF) ablation, or electroporation. As shown in
In a preferred variation, the threshold may be a “success” threshold, such that if the rate of change (or any singular value, such as an initial baseline value) of the biomechanical property is at and/or above the success threshold, the patient is predicted to respond positively to the continued treatment plan. Furthermore, in this variation, if the rate of change does not meet the success threshold, then the patient is predicted to not respond favorably to the treatment. The exact comparison of the rate of change or other trend relative to the threshold depends on the specific biomechanical property. For example, if the rate of change in acoustic speed in a primary tumor in a particular patient is a declining slope that is steeper than the slope of the success threshold, then the particular patient is predicted to respond positively to the continued treatment plan. However, for other biomechanical properties, the patient may be predicted to respond positively if the rate of change is an inclining slope that is steeper than the slope of the success threshold. Alternatively, the threshold may be considered a “fail” threshold.
Predicting response of the tissue S140 may be additionally and/or alternatively include any suitable characteristic of the set of average values of the biomechanical property. For example, in one alternative variation, predicting response of the tissue S140 includes analyzing the general shape of the curve formed by a plot of the set of average values against a temporal variable. In another variation, predicting response of the tissue S140 includes analyzing the initial starting value of biomechanical property in the set of average values. In yet another variation, predicting response of the tissue S140 includes analyzing the trend of one or more biomechanical property and/or morphological characteristic relative to another biomechanical property and/or morphological characteristic. For example, analyzing the trend may include analyzing the spread or distribution of values on a multi-dimensional plot that has values of one biomechanical property (e.g., acoustic speed) on one axis, values of another biomechanical property (e.g., acoustic attenuation), and potentially a temporal variable on a third axis. In another example, analyzing the trend may include analyzing the trend of the ratio between two biomechanical properties (or general shape of the curve formed by a plot of the ratios against a temporal variable).
The method may further include modifying the treatment plan based on the predicted response S150, which functions to utilize the predicted response of the tissue to most benefit the patient. For example, if the prediction is that the patient will respond favorably to the treatment plan, then the step of modifying the treatment plan based on the predicted response S150 may include maintaining the current treatment plan and/or continuing to monitor the physiological response of the patient. As another example, if the prediction is that the patient will not respond favorably to the treatment, then the step of modifying the treatment plan may include: altering characteristics of the treatment plan (such as type of dose, dosage amount, dosage frequency, or distribution pattern of radiation or ablation), administering a different kind of treatment, or aborting the treatment plan. Other suitable modifications, dependent on the specific nature and status of the patient as known by one skilled in the art, may be at the physician's discretion.
As a person skilled in the art will recognize from the previous detailed description and from the figures and claims, modifications and changes can be made to the preferred embodiments of the invention without departing from the scope of this invention defined in the following claims.
This application claims the benefit of U.S. Provisional Application No. 61/304,256 filed 12 Feb. 2010, which is incorporated in its entirety by this reference.
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Number | Date | Country | |
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20110201928 A1 | Aug 2011 | US |
Number | Date | Country | |
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61304256 | Feb 2010 | US |