Pathological Response Calculation Tool for Lung Cancer Specimens
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Solution Overview
Problem
There is a lack of established guidance and precise definitions for processing and evaluating resected lung cancer specimens after neoadjuvant therapy, particularly in clinical trials and clinical practice, which hinders consistent assessment of pathological responses such as major pathological response (MPR) or pathological complete response (pCR).
Innovation Solution
A computer-implemented method for assessing MPR or pCR in lung cancer specimens, which involves receiving data input including dimensions and percentages of sample areas with viable cells, necrosis, and stroma, computing weighted percentages, and determining if specified conditions are met based on thresholds, thereby facilitating consistent and standardized evaluation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual pathological assessment methods are used for resected lung cancer specimens, then pathologists can evaluate treatment response, but there is a lack of consistent guidance and precise definitions leading to variability in assessing MPR or pCR
Solution Approach 1:
The patent transforms the pathological assessment from a purely qualitative manual process to a quantitative computational process by defining specific parameters (viable cell percentage, necrosis percentage, stroma percentage) and using computer algorithms to calculate weighted percentages. This parameterization enables precise, consistent determination of MPR and pCR across different specimens and pathologists.
Solution Approach 2:
The patent replaces the manual mechanical assessment process with a computer-implemented automated system. The computer calculates weighted percentages of viable cells, necrosis, and stroma based on input data, automatically determining MPR or pCR status. This substitution eliminates inter-observer variability and ensures consistent application of assessment criteria.
2Stability of the object's composition
If standardized pathological assessment criteria are established, then consistency in evaluating MPR or pCR can be improved, but the complexity of data processing and computation increases
Solution Approach 1:
The patent segments the pathological assessment into distinct, manageable components: (1) determining percentage of viable cells, (2) determining percentage of necrosis, (3) calculating weighted percentage of viable cells using the formula: weighted % = (% viable cells) × (1 - % necrosis) × (1 - % stroma), and (4) comparing the weighted percentage against established thresholds. This segmentation simplifies the overall process while maintaining consistency.
Solution Approach 2:
The computer-implemented system performs self-service by automatically calculating the weighted percentages and determining MPR or pCR status based on predefined criteria. The system self-regulates by comparing calculated values against established thresholds, eliminating the need for manual judgment and ensuring consistent application of assessment standards across all specimens.
3Stability of the object's composition
If computer-implemented tools are introduced to enforce consistency in pathological assessment, then evaluation standardization can be improved, but the ease of operation for pathologists decreases
Solution Approach 1:
The patent introduces an intermediary computational layer between the pathologist's observation and the final assessment conclusion. The computer acts as a mediator by accepting input data (percentages of viable cells, necrosis, stroma) from pathologists and automatically performing the complex weighted calculations and threshold comparisons. This intermediary handles the mathematical complexity while pathologists focus on accurate data collection.
4Measurement precision
If multiple parameters (viable cells, necrosis, stroma) are measured and weighted calculated, then assessment accuracy is improved, but the time required for data collection and processing increases
Solution Approach 1:
The patent applies preliminary action by pre-establishing the weighting methodology and determination thresholds before actual assessment begins. The weighted percentage formula and MPR/pCR thresholds are predetermined and programmed into the system. During assessment, pathologists only need to input the three percentage values, and the computer instantly performs the calculation and determination, minimizing processing time while maintaining high accuracy.
Data Source
AI summary
In one embodiment, a method includes, for each of a set of samples, receiving data input that includes dimensions of a sample area, a percentage of the sample area being viable cells, and a percentage of the sample area exhibiting necrosis. The method includes, for each of the set of samples, computing a percentage of the sample area being stroma. The method includes, for each of the set of samples, computing weighting factors. The method includes computing a weighted percentage of the set of samples being viable cells based on the computed weighting factor and percentage of the sample area being viable cells for each of the set of samples. The method includes determining that a specified condition is detected in the set of samples based on the computed weighted percentage of the set of samples being viable cells satisfying a threshold correlating with an indication of the specified condition.