Friday, June 27, 2025 6/27/2025

Supine Breast MRI Standardization for Breast Cancer Locator

Award Number: R44CA232862
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/12/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2022

Group Awards By:

View Award Description

Supine Breast MRI Standardization for Breast Cancer Locator - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Detection and Diagnosis Research	000	3	8/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,115,118 )
2020	2020	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Detection and Diagnosis Research	000	3	8/12/2020	NON-COMPETING CONTINUATION	$1,115,118
														Subtotal = $1,115,118

Issue Date FY: 2019 ( Subtotal = $876,342 )
2019	2019	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Detection and Diagnosis Research	001	2	9/5/2019	EXTENSION WITH OR WITHOUT FUNDS	$879,124
2019	2018	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Detection and Diagnosis Research	000	1	7/18/2019	NEW	-$2,782
														Subtotal = $876,342

Issue Date FY: 2018 ( Subtotal = $221,343 )
2018	2018	CAIRNSURGICAL, INC.	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Cancer Detection and Diagnosis Research	000	1	9/12/2018	NEW	$221,343
														Subtotal = $221,343

Grand Total All Awards = $2,212,803

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Supine Breast MRI Standardization for Breast Cancer Locator

Award Number: R44CA232862

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/12/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2022

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer