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BioSensics LLC SBIR Phase I Award, September 2020

A SBIR Phase I contract was awarded to BioSensics LLC in September, 2020 for $256,000.0 USD from the U.S. Department of Health & Human Services and National Institutes of Health.

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sbir.gov/node/1917659
Is a
SBIR/STTR Awards
SBIR/STTR Awards

SBIR/STTR Award attributes

SBIR/STTR Award Recipient
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BioSensics LLC
0
Government Agency
0
Government Branch
National Institutes of Health
National Institutes of Health
0
Award Type
SBIR0
Contract Number (US Government)
1R43CA254835-01A10
Award Phase
Phase I0
Award Amount (USD)
256,0000
Date Awarded
September 14, 2020
0
End Date
August 31, 2021
0
Abstract

PROJECT SUMMARY/ABSTRACTBone lesions are frequently encountered during every day clinical practice. Benign bone lesions, such as a small enchondroma, can be left alone and are unlikely to impact the patient during their lifetime. However, a malignant bone lesion, such as an osteosarcoma, will require a biopsy and surgical resection. Determining which lesions require treatment and which can be left alone can be a daunting process. Whether a bone lesion requires a biopsy depends on both clinical- and imaging-based factors(1–3). Advanced patient age, presence of pain, and history of prior malignancy can influence the need for biopsy. For imaging, various lesion-based parameters such as location, matrix, tumor margin, presence of soft tissue component, and periosteal reaction can help determine whether the lesion is aggressive or non-aggressive, with aggressive lesions needing a biopsy. Aggressive lesions are more likely to represent a malignancy, althought there are some benign processes that can have an aggressive imaging appearance (i.e osteomyelitis, fractures).Misdiagnoses of malignant tumors as benign prevents needed treatment from occurring; however, benign lesions should not be unnecessarily biopsied, as this can lead to unneeded tests, biopsy complications, increased health care costs, and patient anxiety. Currently, the decision to biopsy or not is made by the clinician, considering the clinical- and imaging-based factors, which can be very subjective. Studies have shown that misdiagnosis is higher if these cases are not discussed under multidisciplinary review with input from an orthopedic oncologist, radiologist, and pathologist. Also, if the imaging studies are not interpreted by subspecialty trained musculoskeletal (MSK) radiologists, reading discrepancy of up to 28% can occur. Moreover, a recent study by Zamora et al. showed that there is poor inter-observer agreement amongst experienced orthopedic oncologists for distinguishing enchondromas and chondrosarcomas, a common clinical dilemma.Therefore, we propose to develop a method to analyze the radiologic studies directly, extract important lesion-based features of the bone tumors and auto-classify the lesions as non-aggressive or aggressive. By using CT scans from 200 biopsied bone lesions, utilizing a deep learning approach to extract image features and access to patientsandapos; clinical-based factors, we will develop a machine learning tool to differentiate between non- aggressive and aggressive tumors and compare the results to definitive histologic confirmation of disease. We hypothesize that the proposed machine learning based software will classify aggressive vs. non- aggressive lesions as accurately as definitive histologic confirmation of disease state. The aims of the study are to: 1) Develope bone and lesion segmentation and bone-lesion feature extraction software tools for physician classification; and 2) Develope a software tool to auto-classify femur lesions as either aggressive or non-aggressive.PROJECT NARRATIVEBone tumors are frequently encountered during every day clinical practice. Non-aggressive bone tumors can often be left alone. However, an aggressive bone tumor typically requires a biopsy and subsequent surgery. Determining which lesions require treatment and which can be left alone can be a daunting process. Therefore, our goal is to develop, test, and commercialize a software tool to aid in differentiating between aggressive and non-aggressive bone tumors.

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