ELECTRICAL BIOIMPEDANCE ANALYSIS AS A BIOMARKER OF BREAST DENSITY AND/OR BREAST CANCER RISK
First Claim
1. A method for estimating the percent mammographic density (MD) of at least one breast of an individual, the breast comprising an overlying skin surface and nipple, the method comprising the following steps:
- (A) establishing a connection between a first electrode and subepithelial parenchymal tissue in the breast of the individual;
(B) placing at least one second electrode in contact with the skin surface of the breast proximate the subepithelial tissue at a fixed distance from the nipple of the breast;
(C) establishing at least one electrical signal having a frequency between the first and second electrodes;
(D) measuring the subepithelial impedance (Zsub) at least one frequency between the first and second electrode;
(E) obtaining an estimate of the density of the breast according to an algorithm relating Zsub to mammographic breast density estimated or calculated according to a method independent of steps (A) through (D).
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Accused Products
Abstract
Methods and systems are provided for the noninvasive measurement of the subepithelial impedance of the breast and for assessing the risk that a substantially asymptomatic female patient will develop or be at substantially increased risk of developing proliferative or pre-cancerous changes in the breast, or may be at subsequent risk for the development of pre-cancerous or cancerous changes. A plurality of electrodes are used to measure subepithelial impedance of parenchymal breast tissue of a patient at one or more locations and at least one frequency, particularly moderately high frequencies. The risk of developing breast cancer is assessed according to measured and expected or estimated values of subepithelial impedance for the patient and according to one or more experienced-based algorithms. Devices for practicing the disclosed methods are also provided.
98 Citations
14 Claims
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1. A method for estimating the percent mammographic density (MD) of at least one breast of an individual, the breast comprising an overlying skin surface and nipple, the method comprising the following steps:
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(A) establishing a connection between a first electrode and subepithelial parenchymal tissue in the breast of the individual; (B) placing at least one second electrode in contact with the skin surface of the breast proximate the subepithelial tissue at a fixed distance from the nipple of the breast; (C) establishing at least one electrical signal having a frequency between the first and second electrodes; (D) measuring the subepithelial impedance (Zsub) at least one frequency between the first and second electrode; (E) obtaining an estimate of the density of the breast according to an algorithm relating Zsub to mammographic breast density estimated or calculated according to a method independent of steps (A) through (D). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for assessing the risk that a substantially asymptomatic female patient will be found to have proliferative or pre-cancerous changes in the breast, or may be at subsequent risk for the development of pre-cancerous or cancerous changes, said method comprising the following steps:
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(A) establishing a connection between a first electrode and subepithelial parenchymal tissue in the breast of the patient; (B) placing at least one second electrode in contact with the skin surface of the breast proximate the subepithelial tissue at a fixed distance from the nipple of the breast; (C) establishing at least one electrical signal having a frequency between the first and second electrodes; (D) measuring the subepithelial impedance at least one frequency between the first and second electrode; (E) obtaining an estimate of subepithelial impedance (Zsube) of parenchymal breast tissue for the patient according to variables pertaining to the patient based on the following equation;
Zsube=107.753+(1.083*Age)+(−
1.074*Breast Density)+(3.196*Body Mass Index);wherein Age is measured in years;
Breast Density is expressed in % and is estimated from the appearance of the breast(s) on a mammogram; and
Body Mass Index, BMI, is defined as;Wt (lbs)*703)/Height2(inches ), or Wt (lbs)*4.88/Height2(ft2); (F) obtaining at least one measured value of subepithelial impedance (Zsubm) of parenchymal breast tissue for the patient; and (G) calculating a value for the ratio of Zsubm/Zsube; wherein there is a statistically significant increased risk that the female patient will be found to have breast cancer or be at increased risk of developing breast cancer provided that the ratio of Zsubm/Zsube is less than about 0.8 or greater than about 1.2.
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10. A computer-readable medium having computer-executable instructions for performing a method for assessing the risk that a substantially asymptomatic female patient will be found to have breast cancer or be at increased risk of developing breast cancer, or may be at subsequent risk for the development of pre-cancerous or cancerous changes, the method comprising the following steps:
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(A) establishing a connection between a first electrode and subepithelial parenchymal tissue in the breast of the patient; (B) placing at least one second electrode in contact with the skin surface of the breast proximate the subepithelial tissue at a fixed distance from the nipple of the breast; (C) establishing at least one electrical signal having a frequency between the first and second electrodes; (D) measuring the subepithelial impedance at least one frequency between the first and second electrode; (E) calculating an estimate of subepithelial impedance (Zsube) of parenchymal breast tissue for the patient according to input values for variables pertaining to the patient based on the following equation;
Zsube=107.753+(1.083*Age)+(−
1.074*Breast Density)+(3.196*Body Mass Index);wherein Age is measured in years;
Breast Density is expressed in % and is estimated from the appearance of the breast(s) on a mammogram; and
Body Mass Index, BMI, is defined as;Wt (lbs)*703)/Height2(inches2), or Wt (lbs)*4.88/Height2(ft2); (F) obtaining at least one measured value of subepithelial impedance (Zsubm) of parenchymal breast tissue for the patient; and (G) calculating a value for the ratio of Zsubm/Zsube; wherein there is a statistically significant increased risk that the female patient will be found to have breast cancer provided that the ratio of Zsubm/Zsube is less than about 0.8 or greater than about 1.2.
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11. A computer-readable medium having computer-executable instructions for performing a method for estimating the percent mammographic density (MD) of at least one breast of an individual, the breast comprising an overlying skin surface and nipple, the method comprising the following steps:
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(A) establishing a connection between a first electrode and subepithelial parenchymal tissue in the breast of the individual; (B) placing at least one second electrode in contact with the skin surface of the breast proximate the subepithelial tissue at a fixed distance from the nipple of the breast; (C) establishing at least one electrical signal having a frequency between the first and second electrodes; (D) measuring the subepithelial impedance (Zsub) at least one frequency between the first and second electrode; (E) calculating an estimate of the density of the breast according to an algorithm relating Zsub to mammographic breast density estimated or calculated according to a method independent of steps (A) through (D). - View Dependent Claims (12, 13, 14)
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Specification