SBIR-STTR Award

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.

Project Terms:
3D Print; Adoption; arm; base; Breast; Breast Cancer Patient; breast exam; breast imaging; Breast Magnetic Resonance Imaging; Breast-Conserving Surgery; Businesses; Clinical; Clinical Research; Clinical Trials; cloud based; Coiled Bodies; Complex; Computers; contrast enhanced; cost; Data; design; Development; Device Designs; Devices; Economics; efficacy testing; Enrollment; Ensure; Excision; Feedback; Goals; Health Care Costs; Healthcare; Hospitals; Image; image guided; improved; Information Technology; Ink; innovation; Institution; Lateral; Localized Malignant Neoplasm; Location; Magnetic Resonance Imaging; Maintenance; malignant breast neoplasm; Malignant Neoplasms; Manuals; manufacturing process; Medical Imaging; Meta-Analysis; MRI Scans; Multicenter Studies; Nipples; novel; novel therapeutics; Operative Surgical Procedures; Optics; Patients; Phase; Positioning Attribute; Printing; Procedures; Process; Production; prognostic; Prone Position; Protocols documentation; quality assurance; radiologist; Radiology Specialty; Randomized; Recurrence; research clinical testing; Research Infrastructure; Research Personnel; Scanning; Secure; Services; Shapes; Site; standard of care; Standardization; success; Supination; Surface; Surgeon; surgery outcome; Surgical margins; System; Technology; Testing; Validation; Vendor; volunteer; Woman; Work;

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.

Public Health Relevance Statement:
Narrative: Development and standardization of supine breast MRI is proposed to enable commercial viability of the Breast Cancer Locator (BCL), a surgical guidance device designed to improve the accuracy of cancer resection during breast conserving surgery (BCS). In this Fast Track project, CairnSurgical will test the feasibility of a body coil support platform, test efficacy of an abbreviated supine MRI protocol as an add on to standard-of-care prone breast MRI and establish imaging workflow efficiencies in single and multicenter settings.

Project Terms:
3-Dimensional; 3D Print; Adoption; arm; base; Breast; Breast Cancer Patient; breast exam; breast imaging; Breast Magnetic Resonance Imaging; Breast-Conserving Surgery; Businesses; Clinical; Clinical Research; Clinical Trials; cloud based; Coiled Bodies; Complex; Computers; contrast enhanced; cost; Data; design; Development; Device Designs; Devices; Economics; efficacy testing; Enrollment; Ensure; Excision; Feedback; Goals; Health Care Costs; Healthcare; Hospitals; Image; image guided; improved; Information Technology; Infrastructure; Ink; innovation; Institution; Lateral; Localized Malignant Neoplasm; Location; Magnetic Resonance Imaging; Maintenance; malignant breast neoplasm; Malignant Neoplasms; Manuals; manufacturing process; Medical Imaging; Meta-Analysis; MRI Scans; Multicenter Studies; Nipples; novel; novel therapeutics; Operative Surgical Procedures; Optics; Patients; Phase; Positioning Attribute; Printing; Procedures; Process; Production; prognostic; Prone Position; Protocols documentation; quality assurance; radiologist; Radiology Specialty; Randomized; Recurrence; research clinical testing; Research Personnel; Scanning; Secure; Services; Shapes; Site; standard of care; Standardization; success; Supination; Surface; Surgeon; surgery outcome; Surgical margins; System; Technology; Testing; Validation; Vendor; volunteer; Woman; Work