BlueCross BlueShield of Tennessee Medical Policy Manual

Electrical Impedance Scanning of the Breast

DESCRIPTION

Electrical impedance scanning of the breast involves the transmission of continuous electricity into the body using either an electrical patch attached to the arm or a handheld cylinder. The electrical current travels through the breast where it is then measured at skin level by a probe placed on the breast. Cancerous tissue conducts electricity differently than normal tissue; therefore, cancerous images may show up on the resulting imaging as a bright white spot.

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 patients 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. This device provides the radiologist with additional information to guide a biopsy recommendation.”

The T-Scan™ 2000ED was designed to screen younger women (ages 30-39) for breast cancer in the primary care setting. The device is fundamentally the same as the T-Scan™ 2000, however, the post-processing software has been altered to maximize the specificity of the test. It reports a binary outcome indicating whether or not the woman is at increased risk of cancer at the time of the test (not over her lifetime). It provides a single result for both breasts combined and does not indicate where any questionable lesion is located. A positive result would have to be followed up by additional breast imaging. The FDA has not approved the device.

POLICY

IMPORTANT REMINDERS

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, be used to alter treatment or is as effective or more effective than currently used methods.

SOURCES

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.

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:  8/10/2017

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