Hemodynamic Noninvasive Skin Cancer Diagnostics

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA203038-01A1
Agency Tracking Number: R44CA203038
Amount: $1,352,765.00
Phase: Phase II
Program: SBIR
Awards Year: 2016
Solicitation Year: 2014
Solicitation Topic Code: 102
Solicitation Number: PAR14-088
Small Business Information
4744 KESWICK CT, San Diego, CA, 92130-1337
DUNS: 079461072
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 MIRIANAS CHACHISVILIS
 (858) 722-0657
 mirianas@alumni.caltech.edu
Business Contact
 MIRIANAS CHACHISVILIS
Phone: (858) 722-0657
Email: mirianas@veriskin.com
Research Institution
N/A
Abstract
DESCRIPTION provided by applicant Skin cancer is the most common form of cancer in the US each year accounting for just under half of all diagnosed cancers million diagnoses and deaths with annual treatment costs of at $ billion Early and accurate diagnosis of skin cancer has significant impact on patient outcomes and health care costs but remains a highly subjective skill with existing diagnostic devices either offering limited positive predictie value or requiring highly specialized training Mis diagnoses results in missed skin cancers as well as large numbers of unneeded referrals to dermatologists and unnecessary biopsies We have been developing a novel method and device for a fast and non invasive detection of skin cancer based on measurements of the temporal dynamics of pressure induced blood flow in the cutaneous tumors The central hypothesis of proposed research is that the dynamics of blood flow in response to external mechanical pressure is different in cutaneous tumors as compared to benign nevi thus presenting a diagnostic opportunity Multiple studies have shown that skin cancer is significantly more vascularized than normal skin or benign nevi while the morphology of tumor vascular network is highly irregular contributing to changes in vascular resistance to blood flow and highly elevated interstitial fluid pressure The proposed method relies on measuring the spatially and temporally resolved light absorption in the cutaneous tumor tissue using an optical probe which also acts as pressure application device The method enables to characterize both the amount of blood displaced under pressure and the dynamics of blood displacement and refill Our preliminary data from a pilot clinical study show that both the volume and the rate of the pressure induced blood flow are significantly higher in cutaneous cancer than in benign nevi Here we propose to design and build more advanced devices to perform more detailed investigation of pressure induced dynamics in basal and squamous cell carcinoma and melanoma tumors to investigate instrument and physiology dependent factors that affect pressure induced hemodynamics in tumor tissue and to improve our data analysis algorithms in order to optimize sensitivity and specificity of our device and to develop and test next generation optimized skin cancer detector The long term goal of the project is to develop a simple to use and low cost non invasive skin cancer diagnostic method and device that will facilitate sensitive specific and non subjective assessment of suspect skin regions by general practice clinicians and nurse practitioners enable precise targeting of patients for biopsies and or escalation of care and provide overall reduction in skin cancer treatment costs PUBLIC HEALTH RELEVANCE Skin cancer is the most common form of cancer in the US accounting for just under half of all diagnosed cancers and deaths each year projected numbers for The annual cost of treating skin cancer in the US was estimated at $ billion in The incidence of skin cancer is rising faster than any other cancer and affects of those over years of age Early detection has significant impact on patient outcomes and health care costs both direct and indirect Skin cancers are mainly diagnosed by dermatologists using visual clinical evaluation This assessment remains highly subjective and results in missed skin cancers as well as a highly variable ratio of benign lesions biopsied to malignancies detected the biopsy ratio is as high as to for specialists At an average cost of $ per biopsy an estimated $ billion is spent on skin biopsies each year while the majority of these biopsies prove to be negative Conversely failure to spot cancer at an early more treat able stage may result in individual treatment costs of well over $ VeriSkin will develop a low cost non invasive skin cancer diagnostic method and device that will facilitate accurate specific and non subjective assessment of suspect skin regions by general practice clinicians and nurse practitioners enable precise targeting of patients for biopsies and or escalation of care resulting in reduction in the number of unneeded referrals to dermatologists and unnecessary biopsies and provide overall reduction in skin cancer treatment costs

* Information listed above is at the time of submission. *

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