Abstract P1-01-06: Diagnostic accuracy of a novel palpation device to improve early detection of breast cancer in low-resource settings
Authors: Costa Maurício M , Rositch Anne F , Pereira Fernanda PA , de Oliveira Hildoberto C , de Oliveira Carolina F , Gomes Nilson , Lopes Flávia PPL 
Published: March 2020

Abstract
Background and objectives: As the most commonly diagnosed cancer in women, breast cancer is projected to reach 1 million cases per year by 2020 in LMICs alone. Although incidence continues to increase in low- to middle-income countries, access to early detection in these high burden areas remain limited, in part due to lack of low-cost efficacious tools where mammography isn’t feasible. Therefore, the aim of this study is to evaluate the diagnostic accuracy of a lower cost, non-invasive, portable device called iBreastExam (iBE) in the detection of clinically relevant breast lesions.
Methods: This study was a prospective non-randomized trial which enrolled women seeking routine screening or follow-up breast diagnostic evaluation from Nova Iguaçu and Rio de Janeiro, Brazil, respectively. Non-pregnant women aged 18 and older were eligible to enroll after providing informed consent. Each woman received an iBE palpation test and then mammography, ultrasound (US), or both, each by a different blinded clinician. For the sake of determining true lesion status, a positive mammogram was considered BIRADS 0, 3-6. A positive US was considered BIRADS 3-6. To assess accuracy of iBE to detect lesions, the sensitivity and specificity were calculated compared to mammography alone, ultrasound alone, or mammography plus ultrasound. For mammography plus US, the mammographic classification was considered the true status except for BIRADS 0, in which case the US classification was considered the truth. Each breast was considered an independent result for the sake of analysis.
Results: The study enrolled and evaluated 226 women (449 breasts)with iBE, with a median age of 54 years old. Of the 434 breasts scanned by both iBE and mammography, 348 were normal by both and 17 lesions were detected by both. The sensitivity and specificity of iBE compared to mammography were 45.9% and 87.7%, respectively. Compared to the 324 US scans, where 258 normal by both and 20 lesions were detected by both, the sensitivity and specificity of iBE were 66.7% and 87.8%, respectively. Compared to mammography plus US, the sensitivity and specificity were 73.9% and 88.0%.
Conclusions: Since iBE is being studied as a tool in resource-limited settings to facilitate early detection of suspicious breast lumps that warrant clinical follow-up, we chose other gold-standard diagnostic modalities and classifications, not detection of cancer, as our comparator. The relatively high specificity highlights the tools’ ability to reduce the pool of women warranting further evaluation but the sensitivity of iBE compared to mammography alone was relatively low. Notable, 15 of the 17 cases missed by iBE were classified as BIRADS 0. When these cases underwent US, the net sensitivity increased to 74%. These data highlight the potential for iBE to strengthen breast cancer early detection programs in LMIC’s and support the need for next generation sensors with improved sensitivity.
Citation Format: Maurício M Costa, Anne F Rositch, Fernanda PA Pereira, Hildoberto C de Oliveira, Carolina F de Oliveira, Nilson Gomes, Flávia PPL Lopes. Diagnostic accuracy of a novel palpation device to improve early detection of breast cancer in low-resource settings [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-01-06.