Abstract

PurposeWe aimed to estimate the incremental cancer detection rate achieved by adding three-dimensional functional infrared imaging (3DIRI) to digital mammography in women with dense breasts.Materials and methodsIn this prospective study conducted between December 2014 and April 2016, 1727 women (median age 56) with percentage volumetric breast density > 6% were recruited at routine screening mammography to undergo additional 3DIRI. The 3DIRI findings were classified as negative or positive. Women with a negative mammography but positive 3DIRI were referred to dynamic contrast-enhanced MRI, whereas all other women underwent routine follow-up based on the mammography finding. Diagnosis of breast cancer was verified by histopathologic examination. The number of women diagnosed with a malignancy formed the basis of our statistical analysis.ResultsMammography detected 7 cancers in 7 women. Of 1692 women with negative mammography, 222 women (13%) had a positive 3DIRI of which 219 underwent MRI. An additional 6 cancers were identified in 5 women, increasing the diagnostic yield from 7 of 1727 (0.41%) to 12 of 1727 (0.69%). The incremental cancer detection rate associated with using 3DIRI to select women for MRI was 5 of 222 (22.5 additional cancers per 1000).ConclusionThe use of 3DIRI to select women for an additional MRI can result in the detection of additional cancers in women with dense breasts, but at the expense of additional false positives and considerably lower positive predictive value of the combined examinations. Additional studies are necessary to evaluate the role of 3DIRI as an adjunct to mammography.Key Points• Use of three-dimensional functional infrared imaging to select women for an MRI in addition to screening mammography has the potential to improve breast cancer detection in women with dense breasts.

Highlights

  • Mammography screening reduces breast cancer mortality, but the sensitivity of mammography declines with increasing breast density; women with extremely dense breasts have a 6 times higher odds of interval cancer compared to women with predominantly fatty breasts [1]

  • The incremental cancer detection rate associated with using 3DIRI to select women for MRI was 5 of 222 which translates to 22.5 additional cancers per 1000 women referred for MRI

  • We used three-dimensional functional infrared imaging (3DIRI) to select 13% (n = 222) of the women with a negative screening mammography for additional screening with MRI and we detected cancers in 5 of the 222 women. This corresponds to an incremental cancer detection rate of 22.5 additional cancers per 1000 women referred for MRI

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Summary

Introduction

Mammography screening reduces breast cancer mortality, but the sensitivity of mammography declines with increasing breast density; women with extremely dense breasts have a 6 times higher odds of interval cancer compared to women with predominantly fatty breasts [1]. In a previous proof of concept study, three-dimensional functional infrared imaging (3DIRI) showed high sensitivity in assessing the likelihood of breast cancer [14] and may be a useful addition to the arsenal of tools in breast cancer diagnosis. This method, based on physiology and metabolic changes, is non-invasive, does not involve ionizing radiation, involves no contact with the breasts, and is thought to operate independent of breast density. This is believed to correspond to the MRI-detected asymmetric increased breast vascularity, a biological marker for breast malignancy [15,16,17,18]

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