Breast Tomographic Ultrasound: The Spectrum from Current Dense Breast Cancer Screenings to Future Theranostic Treatments

Sep 21, 2026

This review examines the scientific scope and clinical vision behind the inventors’ and pioneers’ SoftVue breast tomographic ultrasound (BTUS). Over more than 20 years of collaboration, it reports development culminating in FDA approval for adjunct dense-breast screening. Multi-center trials validate quantitative 2D/3D tissue characterization and localization goals, including mass characterization within BIRADS risk categories. The modality is also positioned as an AI-ready, cost-effective platform, enabling theranostic applications such as time-reversed focused ultrasound for localized hyperthermia, drug delivery, and ablation, while emphasizing patient comfort over mammography.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages20

Reading Time50 min

AccessFree to download

Abstract

Introduction

SoftVue—Breast Density, Risk, Screening and Specificity

Review Breast Tomographic Ultrasound: The Spectrum from Current Dense Breast Cancer Screenings to Future Theranostic Treatments Peter J. Littrup 1,2,*, Mohammad Mehrmohammadi 1 and Nebojsa Duric 1,2 Citation: Littrup, P.J.; Mehrmohammadi, M.; Duric, N. Breast Tomographic Ultrasound: The Spectrum from Current Dense Breast Cancer Screenings to Future Theranostic Treatments. Tomography 2024, 10, 554–573. [https://doi.org/](https://doi.org/)[ ](https://doi.org/)[10.3390/tomography10040044](10.3390/tomography10040044) Academic Editor: Emilio Quaia Received: 24 February 2024 Revised: 3 April 2024 Accepted: 11 April 2024 Published: 15 April 2024 Copyright: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ([https://](https://)[ ](https://)[creativecommons.org/licenses/by/](creativecommons.org/licenses/by/)[ ](creativecommons.org/licenses/by/)[4.0/](4.0/)) . 1 Department of Imaging Sciences, University of Rochester, Rochester, NY 14642, USA; [mohammad_mehr@urmc.rochester.edu](mohammad_mehr@urmc.rochester.edu) (M.M.); [nebojsa_duric@urmc.rochester.edu](nebojsa_duric@urmc.rochester.edu) (N.D.) 2 Delphinus Medical Technologies, Inc., Novi, MI 48374, USA * [Correspondence: peter_littrup@urmc.rochester.edu](Correspondence: peter_littrup@urmc.rochester.edu) Abstract: This review provides unique insights to the scientific scope and clinical visions of the inventors and pioneers of the SoftVue breast tomographic ultrasound (BTUS). Their >20-year collaboration produced extensive basic research and technology developments, culminating in SoftVue, which recently received the Food and Drug Administration’s approval as an adjunct to breast cancer screening in women with dense breasts. SoftVue’s multi-center trial confirmed the diagnostic goals of the tissue characterization and localization of quantitative acoustic tissue differences in 2D and 3D coronal image sequences. SoftVue mass characterizations are also reviewed within the standard cancer risk categories of the Breast Imaging Reporting and Data System. As a quantitative diagnostic modality, SoftVue can also function as a cost-effective platform for artificial intelligence-assisted breast cancer identification. Finally, SoftVue’s quantitative acoustic maps facilitate noninvasive temperature monitoring and a unique form of time-reversed, focused US in a single theranostic device that actually focuses acoustic energy better within the highly scattering breast tissues, allowing for localized hyperthermia, drug delivery, and/or ablation. Women also prefer the comfort of SoftVue over mammograms and will continue to seek out less-invasive breast care, from diagnosis to treatment. Keywords: reflection; sound speed; attenuation; stiffness fusion; theranostic; time-reversed acoustics; hyperthermia 1. Introduction This review of breast tomographic ultrasounds (BTUSs) provides insights to the originsand clinical development of SoftVue (Delphinus Medical Technologies, Inc. Novi, MI, USA; DMT) . The overarching questions we address are: \#1. Why did SoftVue get Food and Drug Administration (FDA) approval for dense breast screening [1], especially in relation to its detection specificity; and \#2. Why is SoftVue NOT like any other current medical breast ultrasounds, such that its quantitative transmission parameters can also provide future breast cancer-targeted therapies? First, some insight into how long SoftVue has been in development, working toward a spectrum of clinical uses. Historical Perspective of SoftVue: From the beginning, SoftVue was NOT intended tobe just another form of automated breast ultrasound (ABUS) . SoftVue was originally developed from meetings between several branches of the National Laboratories at the Barbara Ann Karmanos Cancer Institute in 1999, resulting in the first two patents utilizing SoftVu

FAQs

What is the main purpose of SoftVue breast tomographic ultrasound in dense-breast screening?

SoftVue is used as an adjunct to dense-breast cancer screening, leveraging quantitative tissue characterization to support diagnostic goals.

What evidence supports SoftVue’s diagnostic performance?

The review describes multi-center trial confirmation of tissue characterization and localization using quantitative acoustic differences in 2D and 3D coronal image sequences.

How does SoftVue enable theranostic and future treatment applications?

The review positions SoftVue quantitative acoustic maps and time-reversed, focused ultrasound within a single theranostic device to support localized hyperthermia, drug delivery, and/or ablation.

Sep 21, 2026

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