The Challenge of Dense Breasts

Dense mammogram and small breast cancer seen in the ultrasound image only (Images are for illustrative purposes)

Dense mammogram and small breast cancer seen in the ultrasound image only (Images are for illustrative purposes)

COMPELLING MEDICAL NEED:

  • Over 40,000 annual deaths/yr. due to breast cancer in the US. Early cancer detection saves lives and significant medical costs.

  • Cancers are missed by mammograms in dense breasts.

  • Ultrasound doubles detection rate when added to dense mammograms. (ACR guidelines 3/2018 support ultrasound screening in dense breasts)

  • Half of the women worldwide have dense breasts hiding small cancers.

  • 38 states have laws requiring breast density patient  notification and Federal law now requires mammography facilities include breast density information in reports sent to patients and their physicians.

THE PROBLEM:

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Hand held breast ultrasound can detect many cancers missed by mammograms, BUT has significant limitations preventing its use.

  • Operator’s dependency due to many manual steps cause human errors and variable quality of exams.

     (50% of lesions < 9mm not found* during first scan and 38% of small lesions not found at follow up scans in the American College of Radiology Imaging Network (ACRIN) 6666 trial )

  • Limited reproducibility of images, uncertain localization of lesions which can cause missing small cancers. The position of abnormalities in the breast, including many sub centimeter lesions, is made by visual estimation or measurement with a ruler.

  • Inconsistencies of breast scan coverage. The inclusion of all breast tissue in optimal quality images is needed to prevent missing small cancers, but no confirmation of this important requirement is available with current ultrasound machines.

  • Time consuming exams.

  • Lack of skilled technologists or breast radiologists.

OUR SOLUTION:

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Proprietary Dynamic Anatomical Referencing supports unique features:

Metritrack’s automated mapping technology is designed to deliver unprecedented precision and may reduce exam time due to the elimination of multiple operator dependent steps; resulting in higher quality and efficiency when compared to current whole breast ultrasound exam techniques.

  • Removes many manual steps to obtain standardized, high quality exams in less time.

  • Supports the re-localization of small breast lesions within a few mm***

  • Designed to enable precise whole breast tissue mapping**** to avoid missing small cancers.

  • Precise real time mapping of breast tissue is needed for cross correlation with other modalities to reduce unnecessary testing and replace expensive and unavailable MRI guided procedures or surgery with inexpensive universally available ultrasound guided biopsies. (automated features under development).

THE ADDED VALUE EXPECTED TO BE CREATED BY OUR TECHNOLOGY:

  • Save lives by finding additional small cancers, currently missed due to  ultrasound limitations.

  • Significant cost savings with the timely treatment of additionally found small cancers.

  • Hundreds of millions of dollars saved every year in the US by avoiding  unnecessary procedures.

  • •Estimated over $100,000 savings  per ultrasound machine per year, due to exam time savings.

References:

*Wendie A. Berg, MD, PhD Ellen B. Mendelson, MD, Technologist-performed Handheld Screening Breast US Imaging: How Is It Performed and What Are the Outcomes to Date?,  Radiology, Volume 272,number 1-July 2014

**Grubstein A et al., Analysis of false-negative readings of automated breast ultrasound studies. J Clin Ultrasound. 2017 Jun;45(5):

***    European Congress of Radiology 2018 / C-2153

****  European Congress of Radiology 2014