# Supine Breast MRI Standardization for Breast Cancer Locator

> **NIH NIH R44** · CAIRNSURGICAL, INC. · 2020 · $1,115,118

## Abstract

PROJECT SUMMARY/ABSTRACT:
 CairnSurgical, Inc., a Dartmouth spin-off company, will standardize supine breast MRI to streamline pro-
duction of the Breast Cancer Locator (BCL) as a cancer localization device for use in breast conserving
surgery (BCS) to (i) eliminate wire localization – a moderately effective, somewhat costly and certainly
inconvenient procedure for patients and surgeons – and concomitantly to (ii) reduce positive margin rates and
subsequent re-excision surgeries – a significant but unnecessary burden not only on patients but also on the
cost of healthcare. Specifically, standardization of supine breast MRI will be achieved through a) optimization
and use of standard body coils for breast imaging, b) development and testing of a body coil placement plat-
form to minimize breast deformation and positioning inconsistencies during imaging, and c) development and
testing of an abbreviated supine breast MRI protocol that can be added to a prone breast exam or used
independently. In the proposed Phase I and II (Fast Track) clinical studies, CairnSurgical will collaborate with
Dartmouth researchers and clinicians at partnering institutions to 1) test an adjustable body coil placement
platform in a limited study of 12 volunteers with varying breast cup sizes in MRI scanners from multiple
vendors 2) conduct a 62-patient study with a production-ready version of the body coil placement platform to
establish the viability of an abbreviated supine breast MRI protocol as an add-on procedure to standard-of-care
prone MRI in breast cancer patients, and 3) evaluate the efficacy of the body coil placement platform in a
limited multi-center study involving remote clinical partnering sites. CairnSurgical will also develop and clinically
validate information technology (IT) infrastructure required for efficient transfer of medical images from hospital
servers to CairnSurgical to enable BCL production, manage work orders and generate unique patient
identifiers to ensure traceability of the patient-matched BCL devices, which are critical to widespread clinical
adoption and commercial success of the BCL device. Quality assurance and validation data (both clinical and
non-clinical) obtained from these studies will support 510(k) regulatory filing for the body coil support platform
as an accessory to the BCL device. Positive margin rates associated with contemporary BCS are high (~22%-
42%)9-13, and cause significant strains on patients and the cost of breast healthcare. Meta-analyses of the
impact of surgical margins on local recurrence also confirm that negative margins have a positive prognostic
effect. Thus, CairnSurgical is well positioned to develop and commercialize a potentially practice-changing
approach to BCS for accurate resection of breast cancers.

## Key facts

- **NIH application ID:** 10009299
- **Project number:** 5R44CA232862-03
- **Recipient organization:** CAIRNSURGICAL, INC.
- **Principal Investigator:** Venkataramanan Krishnaswamy
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,115,118
- **Award type:** 5
- **Project period:** 2018-09-12 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10009299

## Citation

> US National Institutes of Health, RePORTER application 10009299, Supine Breast MRI Standardization for Breast Cancer Locator (5R44CA232862-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10009299. Licensed CC0.

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