FIELD OF THE INVENTION
[001] The present invention generally relates to radiology.
[002] More particularly, the present invention relates to the evaluation process for ADC values in probably benign and suspicious malignant breast lesions.
BACKGROUND FOR THE INVENTION:
[003] By reference to CN application no. CN100460031C by Celsion Corp dated 2001-04-12, titled” Method and apparatus for treating breast lesions using microwaves” discloses a method and apparatus for selectively heating cancerous or benign conditions of the breast is achieved by irradiation of the breast tissue with adaptive phased array focused microwave energy. The microwave energy is focused in the breast, by compressing the breast and either inserting a single electric-field probe in the central portion of the breast, or placing two noninvasive electric-field probes on opposite sides of the breast skin. Feedback signals from the electric field probe(s) adjust the microwave phase that is delivered to waveguide applicators positioned on opposite sides of the compressed breast tissue. Temperature feedback sensors measure skin temperatures during treatment to adjust the microwave power delivered to the waveguide applicators to avoid overheating the skin. The microwave energy delivered to the waveguide applicators is monitored in real time during treatment, and the treatment is completed when a desired total microwave energy dose has been administered.
[004] By reference to US application no. US2005027188A1 by Rutgers State University of New Jersey dated 2003-12-15, titled” Method and apparatus for automatically detecting breast lesions and tumors in images” discloses method and apparatus for automatically detecting breast tumors and lesions in images, including ultrasound, digital and analog mammograms, and MRI images, is provided. An image of a breast is acquired. The image is filtered and the contrast of the image is enhanced. Intensity and texture classifiers are applied to each pixel in the image, the classifiers indicative of the probability of the pixel corresponding to a tumor. A seed point is identified within the image, and a region of interest is grown around the seed point. Directional gradients are calculated for each pixel of the image. Boundary points of the region of interest are identified. The boundary points are passed as inputs to a deformable model. The deformable model processes the boundary points to indicate the presence or absence of a tumor.
[005] By reference to US application no. US5003979A by University of Virginia UVA dated 1989-02-21, titled” System and method for the noninvasive identification and display of breast lesions and the like” discloses an image processing, pattern recognition and computer graphics system and method for the noninvasive identification and evaluation of female breast cancer including the characteristic of the boundary thereof using multidimensional Magnetic Resonance Imaging (MRI). The system and method classifies the tissue using a Fisher linear classifier followed by a refinement to show the boundary shape and whether the surface of the carcinoma is lobulated or spiculated. The results are a high information content display which aids in the diagnosis and analysis of breast cancer and to assist in any surgical or other remedial planning. The high information content display also assists in the assessment of the effectiveness of therapies showing any reduction or increase in the size of the carcinoma.
[006] By reference to CN application no. CN109993170A by Shenzhen Shen Wei Medical Technology (suzhou) Co Ltd dated 2019-05-10, titled” A kind of bell figure of breast lesion shows device and equipment” discloses a kind of bell figures of breast lesion to show that device, the device include: molybdenum target image collection module, and CC vertical line distance obtains module, and MLO vertical line distance obtains module, lesions position coordinate determining module and lesion display module.By obtaining the CC molybdenum target image and MLO molybdenum target image of same breast, and it is based respectively on CC molybdenum target image and MLO molybdenum target image acquisition CC vertical line distance and MLO vertical line distance.It is thrown then in conjunction with CC and throws the projecting direction angle between shining according to MLO, by trigonometric function relationship, association lesion can be determined in the lesions position coordinate of bell figure.In this way, the more specific location information of association lesion can be shown in bell figure, the location information of lesion is fast and accurately known convenient for doctor.The invention also discloses a kind of bell figure presentation devices of breast lesion to have corresponding technical effect.
[007] By reference to RU application no. RU2398524C1 by Elena Podolskaya dated 2009-02-17, titled” Method of determining operation access for biopsy of non-palpable breast lesions” discloses surgery and can be applied for determining operation access for biopsy of non-palpable breast lesions. Preoperation ultra sonomammography is performed in supine position with a homolateral arm behind the head, identical to the following patient's position on the operation table. Ultrasonic topometry of non-palpable lesion is carried out. Longitudinal scanning of lesion, in place where the marked edge of the sensor corresponds to lesion edges, is made on skin by means of dye, obtaining projection of lesion length. Transverse scanning is carried out, in a place where the marked edge of the sensor corresponds to lesion edges marked on skin with dye is made and projection of lesion diameter is obtained. Lesion contours are plotted on skin by means of dye. Data about depth of lesion location are analyzed. Localisation of planned skin cut, its form, length, value of indent from lesion edges are determined and line of planned cut is drawn on skin by means of dye.
[008] By reference to CA application no. CA2025255A1 by Advanced Light Imaging Technologies Ltd dated 1990-09-13, titled” Transillumination method and apparatus for the diagnosis of breast tumors and other breast lesions” discloses a method and apparatus for enhancing the contrast of a local area of interest within an electronic image of an object, such as a female breast, which has been transilluminated by non-ionizing radiation such as light or sound. The area of interest may be a cancerous tumor, cyst or another object which differentially absorbs or transmits the radiation. Enhancement of contrast is by normalization of the electronic image. Normalization includes modeling the illumination field of the image to compensate for the non-uniformity of the illumination field, and then combining the modeled field with the original image. Four normalization processes are disclosed: Gaussian curve fitting, geometric mean smoothing, arithmetic mean smoothing, and arithmetic mean smoothing only within the boundary of the local area of interest. Also disclosed is a process for highlighting local areas which are the result of enhanced transmission of the radiation, such as potential cyst sites, and color mapping more than one displayed image. The normalized image may be displayed for analysis.
[009] By reference to US application no. US5079698A by Advanced Light Imaging Technologies Ltd dated 1989-05-03, titled” Transillumination method apparatus for the diagnosis of breast tumors and other breast lesions by normalization of an electronic image of the breast” discloses method and apparatus for enhancing the contrast of a local area of interest within an electronic image of an object, such as a female breast, which has been transilluminated by non-ionizing radiation such as light or sound. The area of interest may be a cancerous tumor, cyst or another object which differentially absorbs or transmits the radiation. Enhancement of contrast is by normalization of the electronic image. Normalization includes modeling the illumination field of the image to compensate for the non-uniformity of the illumination field, and then combining the modeled field with the original image. Four normalization processes are disclosed: Gaussian curve fitting, geometric mean smoothing, arithmetic mean smoothing, and arithmetic mean smoothing only within the boundary of the local area of interest.Also disclosed is a process for highlighting local areas which are the result of enhanced transmission of the radiation, such as potential cyst sites, and color mapping more than one displayed image. The normalized image may be displayed for analysis.
[010] By reference to US application no. US6470217B1 by Celsion Corp dated 2000-04-13, titled” Method for heating ductal and glandular carcinomas and other breast lesions to perform thermal downsizing and a thermal lumpectomy” discloses a method for selectively heating cancerous conditions of the breast including invasive ductal carcinoma and invasive glandular lobular carcinoma, and pre-cancerous conditions of the breast including ductal carcinoma in-situ, lobular carcinoma in-situ, and intraductal hyperplasia, as well as benign lesions (any localized pathological change in the breast tissue) such as fibroadenomas and cysts by irradiation of the breast tissue with adaptive phased array focused microwave energy is introduced. Microwave energy provides preferential heating of high-water content breast tissues such as carcinomas, fibroadenomas, and cysts compared to the surrounding lower-water content normal breast tissues. To focus the microwave energy in the breast, the patient's breast can be compressed and a single electric-field probe, inserted in the central portion of the breast, or two noninvasive electric-field probes on opposite sides of the breast skin, can be used to measure a feedback signal to adjust the microwave phase delivered to waveguide applicators on opposite sides of the compressed breast tissue. The initial microwave power delivered to the microwave applicators is set to a desired value that is known to produce a desired increase in temperature in breast tumors. Temperature feedback sensors are used to measure skin temperatures during treatment to adjust the microwave power delivered to the waveguide applicators to avoid overheating the skin. The microwave energy delivered to the waveguide applicators is monitored in real time during treatment, and the treatment is completed when a desired total microwave energy dose has been administered. By heating and destroying the breast lesion sufficiently, lesions can be reduced in size and surrounding normal breast tissues are spared so that surgical mastectomy can be replaced with surgical lumpectomy or the lesions can be completely destroyed so that surgical mastectomy or lumpectomy is avoided.
[011] However, none of the above-discussed inventions provides such an evaluation process for ADC values in probably benign and suspicious malignant breast lesions.
OBJECTS OF THE INVENTION:
[012] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
[013] The main object of the present invention is to provide an evaluation process for ADC values in probably benign and suspicious malignant breast lesions.
[014] Another object of the invention is to evaluate the ADC values of breast masses by the diffusion weighted sequence.
[015] Another object of the invention is to provide a DWI is a technique where no IV contrast is used.
[016] Another object of the invention, lesions are categorized on the basis of BIRADS classification (ACR V edition).
[017] Another object of the invention, a combination of mammography and sonomammography BIRADS category III, IVA, IVB, IVC are used.
[018] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY OF THE INVENTION:
[019] According to one aspect of our invention, evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions comprising the steps of : a) FNAC / Biopsy reports were analyzed; b) the outcome of histopathology are considered as final diagnosis and compared with DWI ADC findings; c) all data was analyzed with SPSS software version 22.0; d) The data was presented as mean±SD for continuous variables and as frequency or percentage for categorical variables; e) Categorical data has been represented as frequency (number) and proportions (percentages); f) Continuous data has been presented as mean ± standard deviation (SD); g) The chi-square test and student’s test were used for statistical comparison of qualitative and quantitative variables; wherein P values <.005 was considered statistically significant.
[020] In another aspect of the invention, the basic modalities for the detection of the breast lesions are X ray mammography, sonomammography and the breast MRI.
[021] In another aspect of the invention, each of these modalities have their strengths and weaknesses.
[022] In another aspect of the invention, the sensitivity and specificity of picking the breast lesions alone by the single modality is less; however when used in combination increases the detection rate.
[023] In another aspect of the invention, advancement in the MRI Breast, especially the DWI sequence which does not require intravenous (IV) contrast, is an important tool in differentiating the benign and malignant lesions.

BRIEF DESCRIPTION OF DRAWINGS:
[024] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[025] Figure 1: illustrates a evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions, as per an embodiment of the present invention.
[026] Figure 2: illustrates a receiver operating curve showing the cut off value of ADC, as per an embodiment of the present invention.
[027] The referral numerals in the figures refer to: 2, 3, 4, 5, 6, 7, 8, 9 - evaluation process steps.
BRIEF DESCRIPTION OF INVENTION:
[028] The present invention will now be described hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. While the following description details the preferred embodiments of the present invention is not limited in its application to the details of construction and arrangement of the parts illustrated in the accompanying drawings. With reference to the figures, the enclosed description and drawings are merely illustrative of preferred embodiments and represent several different ways of configuring the present invention. Although specific components, materials, configurations and uses of the present invention are illustrated and set forth in this disclosure, it should be understood that a number of variations to the components and to the configuration of those components described herein and in the accompanying figures can be made without changing the scope and function of the invention set forth herein.
[029] The present invention proposes a evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions comprising the steps of : a) FNAC / Biopsy reports were analyzed; b) the outcome of histopathology are considered as final diagnosis and compared with DWI ADC findings; c) all data was analyzed with SPSS software version 22.0; d) The data was presented as mean±SD for continuous variables and as frequency or percentage for categorical variables; e) Categorical data has been represented as frequency (number) and proportions (percentages); f) Continuous data has been presented as mean ± standard deviation (SD); g) The chi-square test and student’s test were used for statistical comparison of qualitative and quantitative variables; wherein P values <.005 was considered statistically significant.
[030] The present invention as illustrated in Figure 1 provides another embodiment of the invention which includes a

[031] In another embodiment the invention provide single MRI sequence in the probably benign and suspicious breast masses on routine investigations and validate its usefulness in terms of its non invasiveness in discriminating the nature of the breast lesions.
[032] In another embodiment, the tools included 1. Conventional mammography machine SIEMENS 3000 NOVA. 2. Ultrasound machine Philips EPIQ 7G with high frequency (5-18 MHz) Linear transducer. 3. Magnetic resonance imaging machine AVANTO, SIEMENS (Germany), 1.5 Tesla with dedicated breast coil. 4. FNAC / Biopsy reports.
[033] In another embodiment, evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions wherein Conventional X ray mammographic examination (mediolateral oblique and craniocaudal views). Sonomammography. On the basis of combined X-ray mammography and sonomammography lesions were assessed and a higher category was assigned using the fifth edition of the American College of Radiology (ACR) Breast Imaging Reporting and Data System (BI-RADS) lexicon. Further diffusion weighted MR images were obtained and ADC values were calculated by manually placing the ROI within lesion on the ADC map and recording the mean value in that ROI. FNAC / Biopsy reports were analyzed.
[034] In another embodiment, the outcome of histopathology was considered as final diagnosis and compared with DWI ADC findings. All data was analyzed with the SPSS software version. The data was presented as mean±SD for continuous variables and as frequency or percentage for categorical variables. Categorical data has been represented as frequency (number) and proportions (percentages). Continuous data has been presented as mean ± standard deviation (SD). The chi-square test and student’s test were used for statistical comparison of qualitative and quantitative variables. P values <.005 was considered statistically significant. Breast carcinoma is an increasing trend in India with increase in morbidity and mortality in Indian females. The basic modalities for the detection of the breast lesions are X ray mammography, sonomammography and the breast MRI. Each of these modalities have their strengths and weaknesses. The sensitivity and specificity of picking the breast lesions alone by the single modality is less. However when used in combination increases the detection rate.
[035] In another embodiment, there have been improvements in the detection of breast carcinoma with widespread application of X ray mammography and sonomammography. However it still remains difficult to diagnose and characterize the lesion especially in dense fibroglandular breast. The limitation of the mammography is the overlapping of tissue which hides the lesions mainly in dense breast. However the sensitivity of picking microcalcification, the early sign of malignancy is markedly reduced on sonomammography. The strength of the sonomammography lies in characterization of the solid or cystic masses. Advancement in the MRI breast, especially the DWI sequence which does not require intravenous (IV) contrast, is an important tool in differentiating the benign and malignant lesions, as proved by the various studies.
[036] In another embodiment, film screen mammography and sonomammography were done on clinically palpable breast masses. The lesions were categorized on the basis of BIRADS classification (ACR V edition). A combination of mammographic and sonomammography BIRADS category III, IVA, IVB, IVC were included in the invention and a higher category was assigned.
[037] In another embodiment, DWI was done for these lesions and ADC values were calculated. All the patients were female with the mean age group of (48.81± 9.53). The majority 46.3% of patients evaluated were between 41-50 years, 22.2% in 51-60 years, 20.4% in 31-40 years and 11.1% in 61-70 years of age group.
[038] In another embodiment, scenario breast carcinoma is the most common cause of cancer related death in females. Early detection of malignancy is essential to decrease morbidity and mortality. Various imaging modalities are used to detect breast lesions, which includes Mammography, sonomammography and breast MRI. However mammography is the basic modality for screening and ultrasound (US) is an adjuvant to it. These modalities are known to have high false positive rates because of their own limitations. DWI MRI is a technique based on diffusivity of water molecules and is quantified by ADC value. High cell proliferation in malignant tumors increases cellular density, creating more barriers to the extracellular water diffusion, reducing the ADC, and resulting in signal loss and vice versa occurs in benign lesions and shows high value. This parameter is used in the invention to discriminate between benign and malignant lesions and helps in reducing unnecessary interventions.
[039] The present disclosure described herein above has several technical advantages including, but not limited to,
? Advancement in the MRI Breast, especially the DWI sequence which does not require intravenous (IV) contrast, is an important tool in differentiating the benign and malignant lesions.
[040] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[041] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.

We Claim:

1. A evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions comprising the steps of : a) FNAC / Biopsy reports were analyzed; b) the outcome of histopathology are considered as final diagnosis and compared with DWI ADC findings; c) all data was analyzed with SPSS software version 22.0; d) The data was presented as mean±SD for continuous variables and as frequency or percentage for categorical variables; e) Categorical data has been represented as frequency (number) and proportions (percentages); f) Continuous data has been presented as mean ± standard deviation (SD); g) The chi-square test and student’s test were used for statistical comparison of qualitative and quantitative variables; wherein P values <.005 was considered statistically significant.
2. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein the basic modalities for the detection of the breast lesions are X ray mammography, sonomammography and the breast MRI; each of these modalities have their strengths and weaknesses.
3. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein the sensitivity and specificity of picking the breast lesions alone by the single modality is less; however when used in combination increases the detection rate.
4. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein advancement in the MRI Breast specially the DWI sequence which do not require intravenous (IV) contrast, is an important tool in differentiating the benign and malignant lesions.
5. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein film screen mammography and sonomammography were done on clinically palpable breast masses.
6. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein the lesions were categorized on the basis of BIRADS classification (ACR V edition); A combination of mammographic and sonomammography BIRADS category III, IVA, IVB, IVC were included in the invention and a higher category was assigned.
7. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein the cut off ADC value was taken as 1.03x10- 3 mm2 /s. 27(48.21%) showed ADC values =1.03 x10- 3 mm2 /s and 19 (33.39%) showed ADC value >1.03 x10- 3 mm2 /s and 10(17.86%) showed no restricted diffusion.
8. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein false negative cases i.e 5 out of 32 lesions showed the ADC values >1.03x10- 3 mm2 /s came out to be malignant on histopathology and all were ductal carcinomas and there was only 1 of 32 lesion that shows no restriction but diagnosed as ductal carcinoma on histopathology. 2 out of 24 benign lesions show ADC <1.03x10- 3 mm2 /s, however came out to be chronic abscess on histopathology.
9. The evaluation process for ADC Values in Probably Benign and Suspicious Malignant Breast Lesions as claimed in claim 1, wherein on the basis of histopathology 57.14% of the lesions were malignant and 42.86% were benign; clinical breast examination, mammography and sonomammography to increase the sensitivity and specificity of the lesions.