DURHAM, NC, United States

Zenalux Biomedical, Inc.

www.zenalux.com
DURHAM, NC, United States
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Bydlon T.M.,Duke University | Barry W.T.,Dana-Farber Cancer Institute | Kennedy S.A.,Duke University | Brown J.Q.,Duke University | And 6 more authors.
PLoS ONE | Year: 2012

Breast conserving surgery (BCS) is a recommended treatment for breast cancer patients where the goal is to remove the tumor and a surrounding rim of normal tissue. Unfortunately, a high percentage of patients return for additional surgeries to remove all of the cancer. Post-operative pathology is the gold standard for evaluating BCS margins but is limited due to the amount of tissue that can be sampled. Frozen section analysis and touch-preparation cytology have been proposed to address the surgical needs but also have sampling limitations. These issues represent an unmet clinical need for guidance in resecting malignant tissue intra-operatively and for pathological sampling. We have developed a quantitative spectral imaging device to examine margins intra-operatively. The context in which this technology is applied (intra-operative or post-operative setting) is influenced by time after excision and surgical factors including cautery and the presence of patent blue dye (specifically Lymphazurin™, used for sentinel lymph node mapping). Optical endpoints of hemoglobin ([THb]), fat ([β-carotene]), and fibroglandular content via light scattering (<μs'>) measurements were quantified from diffuse reflectance spectra of lumpectomy and mastectomy specimens using a Monte Carlo model. A linear longitudinal mixed-effects model was used to fit the optical endpoints for the cautery and kinetics studies. Monte Carlo simulations and tissue mimicking phantoms were used for the patent blue dye experiments. [THb], [β-carotene], and <μs'> were affected by <3.3% error with <80 μM of patent blue dye. The percent change in [β-carotene], <μs'>, and [β-carotene]/<μs'> was <14% in 30 minutes, while percent change in [THb] was >40%. [β-carotene] and [β-carotene]/<μs'> were the only parameters not affected by cautery. This work demonstrates the importance of understanding the post-excision kinetics of ex-vivo tissue and the presence of cautery and patent blue dye for breast tumor margin assessment, to accurately interpret data and exploit underling sources of contrast. © 2012 Bydlon et al.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 244.21K | Year: 2012

DESCRIPTION (provided by applicant): Angiogenesis and hypoxia can significantly influence the efficacy of therapy and the behavior of surviving tumor cells. This important fact is supported by a vast amount of literature on pre-clinical models and clinical studies. There is growing demand for technologies to measure tumor hypoxia and angiogenesis temporally and spatially in vivo to enable advances in drug screening, development and optimization. This is particularly useful in the emerging era of anti-angiogenesis and anti-hypoxia therapies. We propose to develop a portable, low power consumption and low-cost, yet accurate and reliable, multimodality optical spectroscopy system with a novel fiber-optic probe to dynamically characterize tumor hypoxia, angiogenesis, and metabolism as well as tissue drug concentration in small animal models without operator bias. The multimodality optical spectroscopy system will be a laptop or battery powered console with the integration of multiple LEDs, a dual-channel spectrometer, a fiber optic probe, electronics and custom software that can be used to perform both diffuse reflectance and fluorescence spectroscopy in vivo. The fiber-optic probe will include an interferometric pressure sensor that can be used to control the probe-tissue pressure for reliable and reproducible spectroscopic measurement of tissue optical properties. The aims of the proposed work (Phase I) will be to (1) design the core technology using LEDs and an interferometric fiber-optic sensor, (2) characterize its performance metrics and (3) validate its utility in a pre-clinical mammary tumor model. This technology will be extended to include quantitative fluorescence measurements in the Phase II STTR project period along with different probe designs to provide flexibility in implementation of this technology to ectopic (tumors grown on flank) and orthotopic models. The commercial device can be marketed as either a single- modality (diffuse reflectance) or a multi-modality (reflectance and fluorescence) device. The outcome of Phase I will lead to a 1st generation Quantilux device which can be productized while the multi-modality 2nd generation device is being refined.The overall objective in Phase II and beyond will be to develop a marketable version of the device and validate its utility for longitudinal tumor therapy monitoring in mouse tumor models. PUBLIC HEALTH RELEVANCE: Our long-term goal is to develop and commercialize a compact, low power consumption, low-cost, yet accurate and reliable, optical spectroscopy system, to dynamically and non-destructively quantify tumor physiological and morphological endpoints such as angiogenesis and hypoxia in small animal models. This proposal is significantly relevant to public health because angiogenesis andhypoxia can significantly influence the efficacy of therapy and the behavior of surviving tumor cells.


Zenalux Biomedical, Inc. | Entity website

zenaprobe The Zenalux Zenaprobe is a specially designed optical fiber probe that delivers light to the sample, collects the reflected signal and delivers it back to the spectrometer. The Zenaprobe has a unique configuration that assures quantitative results when used with Zenaware software ...


Zenalux Biomedical, Inc. | Entity website


Zenalux Biomedical, Inc. | Entity website

zenaware Zenaware software converts spectroscopic measurements into specific optical endpoints. Zenalux currently offers two software options ...


Zenalux Biomedical, Inc. | Entity website

zenascope PC1 Zenalux offers the Zenascope PC1 in standard and custom configurations. Standard The standard configuration offers quantitative measurement of [Hb], [HbO2] and scattering ...


Zenalux Biomedical, Inc. | Entity website

2608 Erwin Road Suite 148-164 Durham, N C 27705 +1- 919-794-5757 info@zenalux.com


Zenalux Biomedical, Inc. | Entity website

Press Release Zenascope Determines Presence or Lack of Blood Flow During Kidney Surgery Study was the first of its kind conducted using quantitative optical spectroscopy measurement for partial ischemia during partial nephrectomy DURHAM, NC January 06, 2015 Zenalux Biomedical, Inc., a leader in biophotonic diagnostics, reports that the Zenascope was deployed in a recent study by investigators at Tulane University that looked at the feasibility of quantitative diffuse reflectance spectroscopy for targeted measurement of renal ischemia during laparoscopic partial nephrectomy in a large animal model ...


Zenalux Biomedical, Inc. | Entity website


Zenalux Biomedical, Inc. | Entity website

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