# US 8,465,437 B2 · Method and system for measuring lung tissue damage and disease risk

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- Number: US 8,465,437 B2
- Document ID: US8465437B2
- Status: Granted
- Kind: B2
- Application number: 12/620,577
- Filed: 2009-11-17
- Published: 2010-03-11
- Granted: 2013-06-18
- Earliest claimed: 2008-02-13
- Assignees: Kitware, Inc.
- Applicants: Ricardo Avila
- Inventors: Ricardo Avila
- Web page: https://patentgrep.com/patent/US8465437B2

## CPC

- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 5/08: Measuring devices for evaluating the respiratory organs
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 6/482: {involving multiple energy imaging}
- G16H 30/40: for processing medical images, e.g. editing
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 5/4514: {Cartilage}
- A61B 5/4528: {Joints (A61B5/4533, A61B5/4538 take precedence)}
- A61B 6/025: {Tomosynthesis}
- A61B 6/583: {using calibration phantoms}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

This invention relates to a method, system, and devices relating to quantitatively measuring regional lung tissue damage by combining the CT scan measurements of the mineral density deviations and/or mineral composition deviations in airway tissue, with the measurements of airflow lung function measurements.

## Claims

### Claim 1

A method of using a computer processor to assess an individual against lung disease risk comprising: receiving data representing lung X-ray images of an individual, using said data to calculate an X-ray attenuation score from one or more measurements of a density deviation at one or more airway bifurcation locations compared to a density value at a region surrounding the bifurcation, combining the X-ray attenuation score with a lung function score of the individual calculated from one or more lung function measurement tests selected from the group consisting of a CT lung function analysis, a spirometry test, a lung ventilation scan, a lung perfusion scan, and a pH value from an exhaled breath condensate test, and assessing of the individual against a lung disease risk index based on said combined X-ray attenuation score and lung function score.

### Claim 2 (depends on 1)

The method of claim 1, further comprising wherein the spirometry test is FEV1/FVC.

### Claim 3 (depends on 1)

The method of claim 1, further comprising wherein the CT lung function analysis includes a CT wall thickness measurement, emphysema measurement, or both.

### Claim 4 (depends on 1)

The method of claim 1, further comprising wherein the X-ray attenuation score is obtained from an imaging modality selected from the group consisting of a CT scan, chest X-ray, digital radiography, X-ray tomosynthesis, and computer aided X-ray radiography.

### Claim 5 (depends on 1)

The method of claim 1, further comprising wherein the density deviation is a measure of calcification, particle deposition, ossification, or combinations thereof.

### Claim 6 (depends on 1)

The method of claim 1, further comprising the steps of measuring over time the lung disease risk index and establishing a disease trajectory for the individual.

### Claim 7 (depends on 5)

The method of claim 5, further comprising the steps of measuring over time the lung disease risk index and establishing a trajectory for the individual.

### Claim 8 (depends on 5)

The method of claim 5, wherein the CT lung function scan includes measurements of a shape change in the one or more bifurcations comprising a thickening of the lung tissue at the bifurcation or surrounding tissue, or a loss of tissue or hole in the lung tissue at the bifurcation or surrounding tissue.

### Claim 9 (depends on 1)

The method of claim 1, further comprising wherein measuring density deviations further comprises measuring the sum of the logs of maximum HU density deviations from nearby low exposure regions along the airway tree in a CT scan.

### Claim 10 (depends on 1)

The method of claim 1, further comprising wherein the lung disease risk index is a lung cancer risk index.

### Claim 11 (depends on 1)

The method of claim 1, further comprising the step of identifying locations that represent high lung cancer risk.

### Claim 12 (depends on 1)

The method of claim 1, further comprising the step of identifying specific lung regions or lobes that represent high lung cancer risk by calculating a region-specific or lobe-specific lung cancer risk index by combining a region-specific X-ray attenuation score with a region-specific lung function score, wherein the region-specific X-ray attenuation score is obtained by applying a lung region-specific classifier to the X-ray attenuation score to identify lung region-specific data subsets of bifurcation locations, and the region-specific lung function score is obtained by modifying the lung function score based upon factors affecting regional airflow.

### Claim 13

An imaging system for lung disease, comprising: an X-ray imaging modality; and a computer programmed to: receive data representing lung X-ray images of an individual, use said data to calculate an X-ray attenuation score from one or more measurements of a density deviation at one or more airway bifurcation locations compared to a density value at a region surrounding the bifurcation, and combine the X-ray attenuation score with a lung function score of the individual calculated from one or more lung function measurement tests selected from the group consisting of a CT lung function analysis, a spirometry test, a lung ventilation scan, a lung perfusion scan, and a pH value from an exhaled breath condensate test, wherein said combined X-ray attenuation score and lung function score provides an assessment of the individual against a lung disease risk index.

### Claim 14 (depends on 13)

A method for preparing a data set that provides an estimation of a patient's lung cancer risk, using the imaging system of claim 13, comprising:
(i) obtaining a measurement of the pH of the lung using an exhaled breath condensate (EBC) device;
(ii) obtaining results of a pulmonary function test obtained by spirometry;
(iii) obtaining a measurement of the level of X-ray attenuation in the airways and calculating a bifurcation damage index (BDI); and,
(iv) combining the pH, spirometry, and X-ray attenuation into a single lung cancer risk index.

### Claim 15 (depends on 14)

The method of claim 14, further comprising the step of applying a classifier to the distribution of measurements to separate lung cancer risk levels and patient sub-populations, COPD patient populations, individuals at risk and patients having other pulmonary related diseases.

### Claim 16 (depends on 13)

The imaging system of claim 13, further comprising wherein the imaging modality is selected from the group consisting of a CT scan, chest X-ray, digital radiography, X-ray tomosynthesis, and computer aided X-ray radiography.

### Claim 17 (depends on 13)

The imaging system of claim 13, further comprising wherein the density deviation is a measurement of calcification, particle deposition, ossification, or combinations thereof.

### Claim 18 (depends on 13)

The system of claim 13, further comprising wherein the imaging modality is a multiple energy CT scan and provides features to further distinguish individual response to exposure.

### Claim 19 (depends on 13)

The system of claim 13, further comprising wherein the computer is programmed to compare changes between one or more assessments of lung cancer risk index.

### Claim 20 (depends on 13)

The system of claim 13, further comprising wherein combining measurements into a lung cancer risk index further comprises adjusting the metric for additional clinical data such as age, gender, smoking history, comorbidity, and family history.

### Claim 21 (depends on 1)

A non-transitory computer readable medium, comprising software code portions for implementing the steps of the method as set forth in claim 1, when said medium is run on a digital computer.