# Evaluating the completeness of scanning in hand-held whole breast ultrasound exams

> **NIH NIH R43** · METRITRACK, INC. · 2020 · $55,000

## Abstract

ABSTRACT:
The project entails the development of a position-tracking system compatible with existing
hand-held ultrasound systems that can track the complete breast volume coverage with a
sufficient level of precision to avoid missing small breast cancers. Scanning the entire breast
for screening breast cancer gained increased interest in recent years, as it was shown that
supplemental screening in women with dense mammograms can significantly increase the
detection rate of small cancers. While detecting sub-centimeter lesions is essential for the
successful treatment of breast cancer, it was shown that around half of all lesions smaller
than 9 mm were not detected by experienced operators12. This significant shortcoming can
be partly attributed to an incomplete scanning of the breast caused by operator's imprecise
visual estimation and also by large-scale deformation of the breast during the procedure. The
resultant localization error can be in the order of a few centimeters and will increase the
likelihood of missing regions of the scanned breast. Current hand-held ultrasound systems
cannot track and document completeness of scanning or alert operators of regions with
incomplete scanning. Metritrack Inc. developed a proprietary method of mapping hand-held
breast ultrasound images that was incorporated in its FDA-cleared automated breast
ultrasound system BVN G-1000. The proposed project intends to develop a method to assess
the volumetric completeness of breast ultrasound scanning, based on the proprietary
mapping method and the obtained clinical data. The project is segmented into two aims. For
aim 1, we will build a software application designed to automatically detect the breast regions
without optimal coverage and guide the operator to obtaining a complete exam. Aim 2 will
evaluate the accuracy and precision of detecting breast regions without optimal coverage.
For this purpose, a customized ultrasound breast phantom with multiple small internal targets
simulating small tumors will be built and scanned under different conditions of deformation,
by 2 operators to simulate clinical conditions of use. We expect that the outcome of this Phase
1 project will demonstrate the feasibility of building the completeness of scanning verification
and guidance application into an automated breast ultrasound system to overcome the
current limitations of breast ultrasound. The prototype will be developed into a commercially
successful product to provide standardized, complete breast ultrasound exams of the whole
breast with a higher cancer detection rate than possible today.

## Key facts

- **NIH application ID:** 10230372
- **Project number:** 3R43CA235912-01A1S1
- **Recipient organization:** METRITRACK, INC.
- **Principal Investigator:** calin caluser
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2019-03-01 → 2020-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10230372

## Citation

> US National Institutes of Health, RePORTER application 10230372, Evaluating the completeness of scanning in hand-held whole breast ultrasound exams (3R43CA235912-01A1S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10230372. Licensed CC0.

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