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The portable, hand-held Intelligent Breast Exam (iBE) device could help more women in resource-limited countries get screened for breast cancer and detect the disease earlier, saving lives, said authors of a study in .

"In lower- and middle-income countries (LMICs), late presentation because of a lack of early clinical evaluation, screening, and diagnosis leads to underdetection, lower incidence, and higher mortality," explained Fardeen Bhimani, MD, of Montefiore Einstein Center for Cancer Care in New York City, and colleagues.

The team conducted a systematic review of 11 studies of the iBE to determine its clinical utility and applicability compared with clinical breast examinations, ultrasound, and mammography, and also evaluated the strengths and weaknesses.

The sensitivity of the iBE ranged from 34.3% to 86% and the specificity from 59% to 94%. For detecting malignant lesions, the device demonstrated a diagnostic capacity of 57% to 93%, and it could identify tumor sizes from 0.5 to 9 cm.

"Our findings underscore the potential clinical utility and applicability of iBE as a prescreening and triaging tool, which may aid in reducing the burden of patients undergoing diagnostic imaging in LMICs," the researchers concluded.

Bhimani discussed additional details and findings in the following interview.

What does the iBE look like, and how is it used?

Bhimani: The Intelligent Breast Exam device is a handheld, wireless, and radiation-free tool designed for breast examination. It is similar to a hand-held ultrasound connected to a mobile device or a tablet via Bluetooth.

The device was initially approved by the FDA in 2013. It utilizes a technology called the piezoelectric finger (PEF) or, in its latest version, the Dynamic Co-Planar Capacitive Sensor (DCPC Sensor). Incorporated into a hand-held compression probe, the PEF or DCPC sensor is used to palpate breast tissue electronically.

During the examination, the iBE is positioned over the breast, offering a feather-touch calibration that automatically senses tissue elasticity differences, providing real-time results. This innovative technology divides the breast into distinct sections, represented as tiles on the connected mobile or tablet device. This section-wise examination allows for a thorough assessment of the entire breast. By directly placing the sensors on the breast, the device measures tissue compression, identifying variations in tissue elasticity upon contact with the skin.

Utilizing sensors, the iBE creates a 3D map that distinguishes normal tissue (depicted in green) from potentially suspicious lesions (depicted in red). Additionally, in case of any suspicious finding, the tiled structure aids in identifying the location and quadrant, providing valuable information for further examination and diagnosis.

What barriers to screening and diagnosis could the device help overcome in low-income countries?

Bhimani: The iBE aims to address several barriers to breast cancer screening and diagnosis in low-income countries. Some key barriers include:

• Cost-effectiveness: Mammography, a commonly used screening tool, can be expensive and require significant infrastructure. The iBE, being a portable, cost-effective device, offers a more affordable option for breast exams and can be used as a prescreening tool in resource-limited settings where performing mammography may be expensive.

• Accessibility: In LICs, there is often a lack of healthcare facilities with mammography equipment and trained personnel. The iBE is designed to be user-friendly and can be operated by individuals with minimal training, including community health workers.

• Radiation-Free Screening: Mammography involves exposure to radiation, and the iBE, being radiation-free, is a safer alternative, especially in settings where infrastructure for radiation-based screening may be limited.

• Real-time results: The iBE provides real-time results, eliminating the need for extensive follow-up visits. This can be particularly advantageous in regions with limited healthcare resources.

How does the iBE compare with other diagnostic tools such as ultrasound and mammography?

Bhimani: Mammography and ultrasound are traditional breast imaging tools, each having limitations. Mammography, for instance, can be expensive, requires trained personnel, and has sensitivity and specificity rates of 87.8% and 90.5%, respectively, which may decrease further in women with dense breast tissue. Ultrasound is effective in detecting masses in dense breasts but is operator-dependent, has a high false-positive rate, and demands skilled technologists and radiologists for interpretation.

In comparison, the iBE presents itself as a portable, cost-effective, and easy-to-use alternative. Our study found that the iBE has shown feasibility and diagnostic accuracy comparable to mammograms and ultrasounds in various settings. However, it's important to note that iBE cannot distinguish benign from malignant lesions, and its sensitivity ranges from 34.3% to 86%, depending on the study; therefore, we advised using this device as a pre-screening tool.

What did you find about patient acceptance of the iBE?

Bhimani: As highlighted in our manuscript, patient acceptance of the iBE appears to be generally positive. Studies conducted in different settings, such as Guam, Nigeria, and rural India, reported moderate to high patient satisfaction rates. Factors contributing to acceptance include the painless nature of the iBE exam, ease of use, and the convenience of real-time results. Furthermore, our study also found that patients, particularly in rural areas, may prefer the iBE over mammography, which is perceived as painful and radiation-intensive.

Read the study here.