Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643767
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Evaluation of the Bexa Breast Examination
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Bexa Breast Examination BBE As an Effective Solution to Breast Cancer Early Detection
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBE
Brief Summary:
Objective
The Bexa Breast Exam or BBE for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable focused ultrasound examination to identify and further evaluate abnormal breast masses including cancer Commercially this combination of Bexa plus focused ultrasound is called Bexa Breast ExamTM and abbreviated as BBE This study compares the Bexa Breast Exam BBE to the standard of care digital breast tomosynthesis in detecting masses and as a breast cancer early detection examination
The specific objectives are
1 To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis in the general population of women over 30 without a history of breast cancer
2 To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis identifying breast masses including cancer in women with dense breasts
3 To demonstrate the proportion of women receiving a BBE that require additional imaging studies
Hypothesis
The purpose of this study is to demonstrate that the Bexa Breast Examinations sensitivity and specificity in identifying abnormal breast masses is comparable to the current accepted standard of care mammography with tomosynthesis
The Bexa Breast Exam or BBE for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable focused ultrasound examination to identify and further evaluate abnormal breast masses including cancer Commercially this combination of Bexa plus focused ultrasound is called Bexa Breast ExamTM and abbreviated as BBE This study compares the Bexa Breast Exam BBE to the standard of care digital breast tomosynthesis in detecting masses and as a breast cancer early detection examination
The specific objectives are
1 To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis in the general population of women over 30 without a history of breast cancer
2 To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis identifying breast masses including cancer in women with dense breasts
3 To demonstrate the proportion of women receiving a BBE that require additional imaging studies
Hypothesis
The purpose of this study is to demonstrate that the Bexa Breast Examinations sensitivity and specificity in identifying abnormal breast masses is comparable to the current accepted standard of care mammography with tomosynthesis
Detailed Description:
Background and Significance
Breast cancer is the second leading cause of cancer deaths among women in the United States It is estimated that 287850 women were diagnosed with breast cancer in 2022 of which 43250 will die The current recommended form of screening for breast cancer is mammography followed by the Clinical Breast Exam CBE However CBE is subjective highly variable depending upon training and experience and lacks the level of sensitivity needed to consistently detect breast masses including cancer
Mammography can be painful irradiates the breast is available primarily in intimidating hospital andor medical clinic locations and requires physician interpretation As well screening mammography results are typically provided to the woman days to weeks after the examination In a study of 405191 mammogram examinations 20 of breast cancers were missed and 12-14 of examinations had false positives results A study published in the February 2016 Annals of Internal Medicine posited that among women receiving annual mammography the radiation exposure caused 246 cancers per 100000 women over a 10-year period
Screening mammography is not adopted by between 30 and 60 of American women over 40 with exaggerated challenges to adoption in the African American and Hispanic communities Mammography is historically not offered to younger women because it is inaccurate in their denser breast tissue Over the past decade the United States Preventive Services Task Force USPSTF has acted to limit the use of mammography in women 40-49 due to the high rate of false positive examinations This has further expanded the population of women at risk for breast cancer without an effective early detection option While annual screening remains the ideal screening frequency to achieve early detection screening mammography recommendations from the USPSTF are driving the transition towards mammograms in women over 50 to every 24 to 36 months primarily as a tactic to limit radiation exposure However this approach renders the women between the ages of 40 and 50 with no options for screening and early detection
Globally less than 5 of at-risk age women will ever receive screening mammography primarily due to the expense of the equipment and of the supporting radiology operations
Efforts must be made to improve the quality and frequency of early detection for all women at risk particularly for those women who do not readily adhere to breast screening guidelines or for whom screening mammography is no longer a recommended option An ideal early detection solution should be pain free radiation free provide immediate results and be easily scalable to vulnerable populations It must have both a low false negative rate and a low false positive rate generating an acceptably low number of unnecessary referrals for additional and unneeded imaging studies In order to make an impact upon the global community at-risk the equipment and its operation must be low-cost efficient accessible and scalable The best cancer screening test is one that patients readily adopt
Bexa Inc has developed a commercially available High-Resolution Pressure Elastography device the Bexa device for the detection of abnormal masses including breast cancer The Bexa device uses highly accurate pressure sensors to perform elastographic evaluation of breast tissue under light compression in conjunction with proprietary image processing algorithms to identify breast masses The device is simple to use which allows consistent results to be produced by different examiners The Bexa device hereafter referred to as Bexa consists of a sensor module similar in shape to a computer mouse with a capacitive sensor array that is connected to a tablet computer to process and visualize the results Bexa has 510k clearance K181672 from the US Food and Drug Administration FDA as a pressure mapping system for documentation of CBE findings under its former commercial name SureTouch Sure Incs proprietary sensor array technology and processing algorithms are ideally suited for application to detection of abnormal breast masses including cancer because the technology is low-cost highly portable free of radiation and consistently adopted by women in all racial and ethnic communities Logistically it addresses several structural and cultural barriers that prevent mass adoption of screening for breast cancer
The Clinical Use of the Bexa Breast Exam
The majority of morbidity and mortality from breast cancer is caused by malignancies that present as solid tumors of the breast The Bexa device produces a clear and accurate image of breast masses as small as 4mm as measured by B-mode ultrasound and misses between 6 and 11 of masses of all types Mammography has a theoretical resolution of 5mm and misses 20 of breast cancers and a higher proportion of all masses Based on prior studies Bexa is the best means of identifying solid masses in the breast including cancer
In the US population Bexa will identify a mass in approximately 8-11 of women and these masses require additional evaluation By comparison mammography has a false-positive rate requiring 12-14 of women to have unnecessary additional evaluation The actual rate of referral for additional studies following screening mammography is often higher based upon claims review and not just false positive findings in the medical literature As well the literature demonstrates the known efficacy of mammography in women older than 50 with no effective solution available in the less than 50 population Compared to mammography the Bexa device used as an early detection technology improves mass detection accuracy while reducing the proportion of women referred for additional and unnecessary imaging studies and biopsies
The results of the BBE are provided to women immediately whereas the results of screening mammogram examinations are require a subsequent non-synchronous interpretation by a radiologist
The most common next-step evaluation of a mass identified by Bexa is an ultrasound of the mass Simple physiologic cysts and benign solid tumors can be easily identified by a focused or spot ultrasound of the detected mass Based upon more than 500 masses identified by Bexa exams performed by ARDMS breast ultrasound technicians up to half have been found to be easily identified as benign This reduces the rate of women referred from a single visit consisting of a Bexa exam combined with spot ultrasound of discovered masses- to less than 4 compared to greater than 12 referred for additional studies following a mammogram
The Bexa Breast Exam process produces accuracy in mass identification that exceeds the limit of lesion size and depth detectable by conventional manual palpation techniques used during a Clinical Breast Exam and digital mammography The Bexa Breast Exam similarly requires that a far smaller proportion of women examined require additional appointments and studies compared to women undergoing mammography
Bexa has the potential to serve as an accurate consistent low-cost early detection modality that can be widely deployed in US and global community settings mobile units as well as traditional and non-traditional primary care settings
Breast cancer is the second leading cause of cancer deaths among women in the United States It is estimated that 287850 women were diagnosed with breast cancer in 2022 of which 43250 will die The current recommended form of screening for breast cancer is mammography followed by the Clinical Breast Exam CBE However CBE is subjective highly variable depending upon training and experience and lacks the level of sensitivity needed to consistently detect breast masses including cancer
Mammography can be painful irradiates the breast is available primarily in intimidating hospital andor medical clinic locations and requires physician interpretation As well screening mammography results are typically provided to the woman days to weeks after the examination In a study of 405191 mammogram examinations 20 of breast cancers were missed and 12-14 of examinations had false positives results A study published in the February 2016 Annals of Internal Medicine posited that among women receiving annual mammography the radiation exposure caused 246 cancers per 100000 women over a 10-year period
Screening mammography is not adopted by between 30 and 60 of American women over 40 with exaggerated challenges to adoption in the African American and Hispanic communities Mammography is historically not offered to younger women because it is inaccurate in their denser breast tissue Over the past decade the United States Preventive Services Task Force USPSTF has acted to limit the use of mammography in women 40-49 due to the high rate of false positive examinations This has further expanded the population of women at risk for breast cancer without an effective early detection option While annual screening remains the ideal screening frequency to achieve early detection screening mammography recommendations from the USPSTF are driving the transition towards mammograms in women over 50 to every 24 to 36 months primarily as a tactic to limit radiation exposure However this approach renders the women between the ages of 40 and 50 with no options for screening and early detection
Globally less than 5 of at-risk age women will ever receive screening mammography primarily due to the expense of the equipment and of the supporting radiology operations
Efforts must be made to improve the quality and frequency of early detection for all women at risk particularly for those women who do not readily adhere to breast screening guidelines or for whom screening mammography is no longer a recommended option An ideal early detection solution should be pain free radiation free provide immediate results and be easily scalable to vulnerable populations It must have both a low false negative rate and a low false positive rate generating an acceptably low number of unnecessary referrals for additional and unneeded imaging studies In order to make an impact upon the global community at-risk the equipment and its operation must be low-cost efficient accessible and scalable The best cancer screening test is one that patients readily adopt
Bexa Inc has developed a commercially available High-Resolution Pressure Elastography device the Bexa device for the detection of abnormal masses including breast cancer The Bexa device uses highly accurate pressure sensors to perform elastographic evaluation of breast tissue under light compression in conjunction with proprietary image processing algorithms to identify breast masses The device is simple to use which allows consistent results to be produced by different examiners The Bexa device hereafter referred to as Bexa consists of a sensor module similar in shape to a computer mouse with a capacitive sensor array that is connected to a tablet computer to process and visualize the results Bexa has 510k clearance K181672 from the US Food and Drug Administration FDA as a pressure mapping system for documentation of CBE findings under its former commercial name SureTouch Sure Incs proprietary sensor array technology and processing algorithms are ideally suited for application to detection of abnormal breast masses including cancer because the technology is low-cost highly portable free of radiation and consistently adopted by women in all racial and ethnic communities Logistically it addresses several structural and cultural barriers that prevent mass adoption of screening for breast cancer
The Clinical Use of the Bexa Breast Exam
The majority of morbidity and mortality from breast cancer is caused by malignancies that present as solid tumors of the breast The Bexa device produces a clear and accurate image of breast masses as small as 4mm as measured by B-mode ultrasound and misses between 6 and 11 of masses of all types Mammography has a theoretical resolution of 5mm and misses 20 of breast cancers and a higher proportion of all masses Based on prior studies Bexa is the best means of identifying solid masses in the breast including cancer
In the US population Bexa will identify a mass in approximately 8-11 of women and these masses require additional evaluation By comparison mammography has a false-positive rate requiring 12-14 of women to have unnecessary additional evaluation The actual rate of referral for additional studies following screening mammography is often higher based upon claims review and not just false positive findings in the medical literature As well the literature demonstrates the known efficacy of mammography in women older than 50 with no effective solution available in the less than 50 population Compared to mammography the Bexa device used as an early detection technology improves mass detection accuracy while reducing the proportion of women referred for additional and unnecessary imaging studies and biopsies
The results of the BBE are provided to women immediately whereas the results of screening mammogram examinations are require a subsequent non-synchronous interpretation by a radiologist
The most common next-step evaluation of a mass identified by Bexa is an ultrasound of the mass Simple physiologic cysts and benign solid tumors can be easily identified by a focused or spot ultrasound of the detected mass Based upon more than 500 masses identified by Bexa exams performed by ARDMS breast ultrasound technicians up to half have been found to be easily identified as benign This reduces the rate of women referred from a single visit consisting of a Bexa exam combined with spot ultrasound of discovered masses- to less than 4 compared to greater than 12 referred for additional studies following a mammogram
The Bexa Breast Exam process produces accuracy in mass identification that exceeds the limit of lesion size and depth detectable by conventional manual palpation techniques used during a Clinical Breast Exam and digital mammography The Bexa Breast Exam similarly requires that a far smaller proportion of women examined require additional appointments and studies compared to women undergoing mammography
Bexa has the potential to serve as an accurate consistent low-cost early detection modality that can be widely deployed in US and global community settings mobile units as well as traditional and non-traditional primary care settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None