You are here

Computed Optical Margin Assessment for Breast Cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44CA165436-02
Agency Tracking Number: R44CA165436
Amount: $1,852,379.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA10-079
Timeline
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
200 South Wacker Drive
CHICAGO, IL 60606-2901
United States
DUNS: 829708903
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ANDREW CITTADINE
 (312) 320-5478
 acittadine@diagnosticphotonics.com
Business Contact
 ANDREW CITTADINE
Phone: (312) 320-5478
Email: acittadine@diagnosticphotonics.com
Research Institution
 Stub
Abstract

DESCRIPTION (provided by applicant): Diagnostic Photonics, Inc. (DxP) is a medical device company developing an intraoperative imaging system for surgical guidance and real-time assessment of cancer tumor margins based on interferometric synthetic aperturemicroscopy (ISAM), a novel modality that uses light defraction to assess tissue. Because of the fatty nature of the breast, current intraoperative histopathologic assessments are time consuming and unreliable. This project tests ISAM while the long term goal is to reduce the number of re-excisions for the management of breast cancer by providing rapid, reliable intraoperative margin assessment without tissue destruction. This will result in significant cost savings by reducing repeat operations. It may eventually result in a reduced volume of resection due to the ability to more accurately identify the extent of resection needed. In Phase I, three specific aims will be accomplished. Phase I aims include the development of a handheld probe and instrumentation support, user interface, and sterile disposable needed for execution of in vivo clinical studies as well as a clinical evaluation of ISAM margin detection versus pathology. The clinical goal in Phase I will be an initial evaluation of ISAM by comparingISAM images against corresponding histology slides. This trial is necessary before proceeding to larger trials and will also serve asa control group for Phase II. The ex vivo assessment of tumor margins using the ISAM device will provide sensitivity and specificity data for the device vs. the gold standard of post-operative histology. The trial results and other data collected such as patient or pathology factors that increase or decrease the rate of margins will allow us to more accurately determine samplesize requirements for Phase II. In Phase II, the ISAM technology will be applied in vivo. Correct labeling and assessment of tumor margins has long been considered a weakness of the current margin assessment methods and has been well documented to be unreliable. It is crucial to develop a technique that can assess margins both ex vivo and in vivo in the specimen cavity. Successfully identifying positive margins at the time of the operation allows the surgeon to act on those positive margins immediately, reducing the number of re-excisions. Aims of Phase II include assessment of in vivo margin analysis, evaluation of the utility of the ISAM system and time required during surgery, and the ultimate reduction in repeat surgeries from positive margins. PUBLIC HEALTH RELEVANCE Breast cancer is one of the leading causes of cancer death among women of all races in the United States. Over 182,000 cases of breast cancer are diagnosed annually An estimated 128,000 of these patients with early stage breast cancer undergo breast conservation surgery ( BCS ), i.e., lumpectomy/partial mastectomy. The literature reports post-surgical positive margins in 20-70% of these patients which then requires a repeat surgery. New methods of reliable cost-effective intra-operative margin assessment are needed to move diagnostic capabilities to the operating room for point-of-care decision-making, and thus reducing the number of repeat surgeries that add cost and risk to the patient. DxP aims to fulfill this unmet need starting with thegoals set for this grant application.

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

US Flag An Official Website of the United States Government