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Validation of Light Scattering Spectroscopy for Intra-operative Margin Guidance during Oral Cancer Resection

Award Number: R01DE029862
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/07/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Validation of Light Scattering Spectroscopy for Intra-operative Margin Guidance during Oral Cancer Resection - PROJECT SUMMARY Nearly 37,000 new cases of oral cancer will be diagnosed in the United States in 2019, and nearly half will die in 5 years. The lethality of this disease is partially attributed to the fact that most cases are in advanced stages when diagnosed. Surgical resection remains a primary modality for treatment but local and regional recurrence remains the most common problem after surgical resection; patients with advanced stage oral cancer experience recurrence rates as high as 60-80% in the first 3 years. Inadequate tumor excision is a common cause for such local recurrence. This could be explained by the imprecise methods currently used for assessing surgical margins and by the presence of “satellite” malignant cells (“skip lesions”) in sites away from the primary cancerous lesion which occur as a result of the “field cancerization” phenomenon. Currently, surgeons often depend on their own judgment or visualization under white light to determine surgical margins. Confirmation of negative margins is based on randomly selected samples for intraoperative frozen section analysis, leaving much of the surgical margin unexamined. Moreover, frozen section analysis can be time consuming, expensive, and have a high false negative rate. A more efficient and precise approach is needed. Optical technologies can be used to distinguish in situ benign from malignant tissue lesions. Elastic Scattering Spectroscopy (ESS) is a point spectroscopic measuring technique that can detect with great sensitivity sub-cellular morphologic differences between benign and malignant tissue. These differences include nuclear size, chromatin granularity or density, organelle sizes and densities, and other sub-cellular features. ESS provides the advantage of real-time, objective and quick assessment of tissue morphology; the optical-spectroscopy equivalent of histopathological readings. Past research demonstrated the ability of ESS to differentiate with good precision normal versus abnormal oral mucosa, in-vivo, during oral cancer surgical resection. The first aim of this current study is to expand on that work by further training the ESS algorithms on a much larger prospective dataset so that the technology can demonstrate clinically acceptable accuracy standards. The second aim of this study is to design and test novel instrumentation capable of differentiating between normal and abnormal tissue on both aspects of the deep margin (tumor and tumor bed). One hundred and twenty patients will be enrolled from Boston Medical Center and from the Boston VA hospitals. ESS measures will be co-registered with histopathological assessments of dysplasia grade and inflammation type. Further refinement of this technology will result in the validation of ESS instrumentation capable of facilitating intraoperative margin guidance. Our hypothesis is that further refinement of our ESS algorithms will greatly improve surgeons' accuracy in determining which tissue should go to frozen section, and will help the surgeon assess proper surgical margins during excision of oral cancers compared to traditional approaches alone. This, in turn, will significantly reduce local recurrence rates and its associated morbidity and mortality.


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: 2024 ( Subtotal = $703,116 )
2024	2024	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL	BOSTON	MA	02118	SUFFOLK	USA	Oral Diseases and Disorders Research	000	5	7/1/2024	NON-COMPETING CONTINUATION	$703,116
														Subtotal = $703,116

Issue Date FY: 2023 ( Subtotal = $717,253 )
2023	2023	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Oral Diseases and Disorders Research	000	4	6/1/2023	NON-COMPETING CONTINUATION	$717,253
														Subtotal = $717,253

Issue Date FY: 2022 ( Subtotal = $709,868 )
2022	2022	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CTR PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Oral Diseases and Disorders Research	000	3	5/31/2022	NON-COMPETING CONTINUATION	$709,868
														Subtotal = $709,868

Issue Date FY: 2021 ( Subtotal = $682,508 )
2021	2021	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Oral Diseases and Disorders Research	001	2	5/24/2021	NON-COMPETING CONTINUATION	$682,508
2021	2020	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Oral Diseases and Disorders Research	000	1	1/14/2021	NEW	$0
														Subtotal = $682,508

Issue Date FY: 2020 ( Subtotal = $753,975 )
2020	2020	BOSTON MEDICAL CENTER CORPORATION	1 BOSTON MEDICAL CENTER PL STE 1	BOSTON	MA	02118	SUFFOLK	USA	Oral Diseases and Disorders Research	000	1	7/7/2020	NEW	$753,975
														Subtotal = $753,975

Grand Total All Awards = $3,566,720

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Validation of Light Scattering Spectroscopy for Intra-operative Margin Guidance during Oral Cancer Resection

Award Number: R01DE029862

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/07/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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