# Detection of Breast Lesions Utilizing iBreast Exam: A Pilot Study Comparison with Clinical Breast Exam

## TL;DR

A new portable device called iBreast Exam was tested for detecting breast cancer and performed similarly to a manual exam by a nurse, but mammography was more effective.

## Contribution

The iBreast Exam device was evaluated as a potential alternative to manual clinical breast exams in areas with limited healthcare access.

## Key findings

- Mammography detected three breast cancers, while iBreast Exam and clinical breast exam detected only one.
- iBreast Exam performed similarly to clinical breast exams in terms of sensitivity and specificity.
- The device may be useful in areas where trained healthcare workers are scarce.

## Abstract

Women without access to standard medical tests to check for breast cancer may benefit from a portable technology to check for possible cancer. This could alert a woman to seek medical care. This study compares a new portable technology designed to examine the breast, called the iBreast Exam, to standard tests including clinical breast exam (a breast examination performed by a nurse with their hands) and an X-ray picture of the breast (mammography). In this pilot study of 300 women, mammography found three breast cancers while iBreast Exam and clinical breast exam found one cancer. Cancers missed by the iBreast Exam and clinical breast exam were small (<2 cm). Mammography remains the best way to check for breast cancer. Given the iBreast Exam performed similarly to the clinical breast exam, it may be helpful in areas where trained healthcare workers are not available to provide a clinical breast exam. Further research is needed.

Background/Objectives: The iBreast Exam (iBE) electronically palpates the breast to identify possible abnormalities. The purpose of this study was to assess iBE feasibility and compare it to Clinical Breast Exam (CBE) for breast lesion detection. Methods: Prospective evaluation of 300 asymptomatic women, ≥18 years old, with CBE, iBE, and mammography was performed. Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of iBE and CBE for detecting suspicious breast lesions were calculated using breast imaging as the reference standard. For women with one year follow up, the sensitivity, specificity, PPV, and NPV for cancer detection were calculated. Results: 300 women (mean age 58.9 years) underwent CBE, iBE, and mammography. In 2/300 (0.7%), CBE was positive; in 1/300 (0.3%), iBE was positive; and in 24/300 (8%), screening mammograms were positive. Nine had suspicious imaging findings with biopsy (three malignant and six benign). Of three cancers, all visualized mammographically, CBE and iBE detected an ipsilateral breast abnormality in one woman and missed two cancers (<2 cm). Sensitivity, specificity, NPV, and PPV of iBE and CBE were similar, with no statistically significant difference in NPV or PPV for detection of suspicious breast findings or breast cancer (p > 0.05). Conclusions: Mammography detected all breast cancers in our cohort and remains the standard of care. iBE is feasible to perform. Our pilot data demonstrates iBE performed similarly to CBE by trained nurse practitioners. Given our small study population, further investigation is warranted into the potential use of iBE where trained healthcare practitioners are not readily available.