You are here

High-resolution Smart Optical Probe for Breast Biopsy Guidance

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42CA114896-02A1
Agency Tracking Number: CA114896
Amount: $857,342.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Solicitation Year: 2009
Award Year: 2009
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
DUNS: 073800062
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (978) 689-0003
Business Contact
Phone: (978) 689-0003
Research Institution
United States

 Domestic Nonprofit Research Organization

DESCRIPTION (provided by applicant): Fine needle aspiration biopsy (FNAB) is a rapid and cost-effective procedure that uses a syringe to sample fluid from a cyst or remove clusters of cells from a solid mass for diagnostic purposes. The effectiveness of FNAB is operator-dependent and the diagnostic yield could be low, especially for adipose- rich tissue and masses where the percentage of non-diagnostics aspirates is relatively high (15-20%). Proper needle placement could substantially reduce the number of the non-diagnostic aspirates and therefore improve the diagnostic yield of the procedure. Advanced techniques now exist to do FNAB guidance, like stereotactic CT or ultrasound, but they are expensive, require additional personnel and they are not always available in small clinics. Physical Sciences Inc. (PSI), in collaboration with Masachusetts General Hospital (MGH), proposes to develop a simple and low-cost instrument based on Low Coherence Interferometry (LCI) that will be used as a guidance tool for needle placement during the FNAB procedure. In Phase I a pre-clinical system was developed and a pilot in vitro clinical study on various tissue specimens was conducted to demonstrate the capability of the system to differentiate tissue types (adipose, fibroglandular, and tumor). An animal study was performed as well to demonstrate the capability of the instrument to differentiate tissue-types in vivo. Phase II of the project will focus on the development of a portable, low cost clinical system with a disposable probe and an expanded clinical study on animals will be performed at the Massachusets General Hospital to prove the effectivness of the instrument in the guidance of FNAB procedures. PUBLIC HEALTH RELEVANCE: Low Coherence Interferometry is a proposed guidance tool for needle placement during an FNAB procedure of a breast mass. With this technology, the pathologist or biopsy physician performing the biopsy will be able to guide the needle to the most diagnostic area of the mass due to the instruments ability to determine the tissue type present at the tip of the needle before taking the sample. The hypothesis is that this technology will decrease the number of non-diagnostic aspirates by increasing the overall yield of tissue representative of the mass. Having confidence that the FNA sample is truly representative of the mass will not only help ensure that patients who do have cancer are properly diagnosed, but will allow patients who do not have cancer and their referring physicians to trust in the negative biopsy results thereby preventing additional, more invasive and unnecessary procedures.

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

US Flag An Official Website of the United States Government