DESCRIPTION
Electrical impedance scanning (EIS) was developed as a confirmatory test to be used in conjunction with mammography. This technology is proposed to detect abnormal breast tissue using small electrical currents based on the belief that malignant tissue is more conductive than normal tissue. During EIS, the individual holds a metal cylinder in one hand, while a probe consisting of multiple electrodes is applied to numerous predefined sites on each breast. Each time the probe touches the breast, an integrated computer system applies a physically imperceptible 0.1- to 2.5-volt alternating current at seven different frequencies, ranging from 100 to 2 million Hertz (Hz). Based on the electric currents recorded at these frequencies, the integrated computer system creates a conductivity map of the breast and identifies sites that appear suspicious.
An example of an electrical impedance scanning device is the T-Scan™ 2000. This device received approval for marketing from the U. S. Food and Drug Administration (FDA) in 1999 with the following labeled indication: "The T-Scan™ 2000 is intended for use as an adjunct to mammography in individuals who have equivocal mammographic findings with ACR Bi-RADS™ categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy.”
POLICY
Electrical impedance scanning of the breast is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
There is a lack of evidence in the published literature to show that electrical impedance scanning for the detection and classification of breast lesions can predict clinical events, alter treatment, or is as effective as currently used methods.
SOURCES
American Cancer Society. (2022). Breast cancer early detection and diagnosis - Newer and experimental breast imaging tests. Retrieved December 19, 2022 from https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/experimental-breast-imaging.html.
Dagler, G., Senol, K., Yakut, Z., Yuksek, Y., Tutuncu, T, Tez, M., & Yesiltepe, C. (2016). Effectiveness of breast electrical impedance imaging for clinically suspicious breast lesions. Bratislavske Lekarske Listy, 117 (9), 505-510. Abstract retrieved June 22, 2017 from PubMed database.
National Comprehensive Cancer Network. (2023, October). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast cancer screening and diagnosis v.3.2023. Retrieved February 19, 2024 from the National Comprehensive Cancer Network.
Raneta, O., Ondruš, D., & Bella, V. (2012). Utilisation of electrical impedance tomography in breast cancer diagnosis. Klinicka Onkologie, 25 (1), 36-41. Abstract retrieved March 11, 2020 from PubMed database.
U. S. Food and Drug Administration. (1999, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. P970033. Retrieved December 19, 2003 from http://www.fda.gov/cdrh/pdf/p970033.html.
U. S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. Advisory Committees. Obstetrics and Gynecology Devices Panel. Retrieved February 10, 2011 from http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm125145.htm.
Vreugdenburg, T., Willis, C., Mundy, L., & Hiller, J. (2013). A systematic review of elastography, electrical impedance scanning and digital infrared thermography for breast cancer screening and diagnosis. Breast Cancer Research and Treatment, 137 (3), 665-676. Abstract retrieved June 22, 2017 from PubMed database.ORIGINAL EFFECTIVE DATE: 6/1/2004
MOST RECENT REVIEW DATE: 3/14/2024
ID_BT
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