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Perioperative Diffuse Optical Imaging of Tissue Blood Flow and Oxygenation for Optimization of Mastectomy Skin Flap Viability

Award Number: R01EB028792
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2020
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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Perioperative Diffuse Optical Imaging of Tissue Blood Flow and Oxygenation for Optimization of Mastectomy Skin Flap Viability - ABSTRACT Mastectomy is performed on approximately half of women with breast cancer. Postmastectomy breast reconstruction has benefits for body image, sexuality, self-esteem, and quality of life. Poor clinical prognoses after breast reconstruction often involve mastectomy skin flap necrosis (MSFN) or other complications associated with the lack of blood flow and oxygenation to wound tissue volumes. MSFN and wound dehiscence leads to a number of challenges, including wound management problems, delays to adjuvant therapy, esthetic compromise, implant extrusion, patient distress, and financial loss. A technology that allows surgeons to perioperatively assess and optimize preservation of skin flaps while avoiding complications is essential to ensure successful clinical outcomes. Although alternative techniques have been explored to identify ischemic-hypoxic tissues at risk of necrosis, none have achieved universal acceptance as each technique has a few challenging issues that decrease its clinical usefulness. Moreover, no single technique provides both blood flow and oxygenation information, which are essential for precise assessment of skin flap viability. Our recent innovative development of near-infrared speckle contrast diffuse correlation tomography (scDCT) technique provides a noninvasive (dye-free) and noncontact means for continuous 2D/3D imaging of blood flow distributions throughout large/thick tissue volumes such as mastectomy skin flaps. We propose to extend this scDCT prototype to a next generation multi-wavelength scDCT (MW-scDCT) device for perioperative imaging of both blood flow and oxygenation distributions in mastectomy skin flaps. New high-speed algorithms for 2D mapping and 3D image reconstruction will be developed to accommodate rapid online assessment of skin flap hemodynamics. This MW-scDCT system will be tested/optimized using standard tissue-simulating phantoms (Aim 1) and calibrated/validated against a commercial dye-based fluorescence angiography device (SPY Elite®) in swine (Aim 2) and patients (Aim 3) undergoing mastectomy with expander-implant based breast reconstruction. The in vivo studies will determine the capability of our MW-scDCT for intraoperative prediction of MSFN regions/volumes and postoperative optimization of incremental expander volumes to reduce risks of MSFN and other complications. We expect that combined measurements of preoperative baseline and intraoperative alteration in skin flap flow and oxygenation will provide a more accurate assessment of skin flap viability than a one-time single-parameter measurement (i.e., blood flow, blood oxygenation, or fluorescence perfusion). Study outcomes will provide the rationale for designing MW-scDCT guided clinical trials of mastectomy with breast reconstruction to reduce postoperative complications and healthcare costs. Moreover, this noninvasive (dye-free), noncontact, continuous, and cost-efficient imaging system has the potential for perioperative use in many other clinical settings, especially where contact measurements may not be possible, such as for continual and longitudinal monitoring of burns, wounds, and other types of tissue flaps.


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: 2025 ( Subtotal = $0 )
2025	2024	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	1/22/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $480,597 )
2024	2024	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	4	5/17/2024	NON-COMPETING CONTINUATION	$39,233
2024	2024	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	002	4	6/18/2024	NON-COMPETING CONTINUATION	$349,540
2024	2024	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	11/30/2023	NON-COMPETING CONTINUATION	$91,824
														Subtotal = $480,597

Issue Date FY: 2023 ( Subtotal = $490,404 )
2023	2023	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	3	1/23/2023	NON-COMPETING CONTINUATION	$49,040
2023	2023	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	11/29/2022	NON-COMPETING CONTINUATION	$441,364
														Subtotal = $490,404

Issue Date FY: 2022 ( Subtotal = $490,404 )
2022	2022	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	6/27/2022	NON-COMPETING CONTINUATION	$49,043
2022	2022	UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, THE	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	2/1/2022	NON-COMPETING CONTINUATION	$441,361
														Subtotal = $490,404

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF KENTUCKY	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	2/12/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $485,381 )
2020	2020	UNIVERSITY OF KENTUCKY	500 S LIMESTONE 109 KINKEAD HALL	LEXINGTON	KY	40526	FAYETTE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	3/13/2020	NEW	$485,381
														Subtotal = $485,381

Grand Total All Awards = $1,946,786

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Perioperative Diffuse Optical Imaging of Tissue Blood Flow and Oxygenation for Optimization of Mastectomy Skin Flap Viability

Award Number: R01EB028792

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/15/2020

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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