USA flag logo/image

An Official Website of the United States Government

Optical surveillance of tumor margins in patients undergoing breast conserving…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85437
Program Year/Program:
2007 / STTR
Agency Tracking Number:
CA128160
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
ENDLS OPTICS CORPORATION
2608 ERWIN RD, STE 148-164 DURHAM, NC 27705-4597
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2007
Title: Optical surveillance of tumor margins in patients undergoing breast conserving su
Agency: HHS
Contract: 1R41CA128160-01
Award Amount: $195,843.00
 

Abstract:

DESCRIPTION (provided by applicant): In 2005, 72,000 women that underwent breast surgery had to have a second re-excision surgery due to incomplete removal of the cancer during the first surgery. Needing a second surgery means increased cancer recurrence, patient anxiety, complications, and cost. Currently, surgeons have no readily available, cost efficient, intraoperative instruments that ensure that the cancer has been completely excised to prevent re-excision. To improve care, surgeons are seeking real time information on the tumor margins at the site of excision. Prior intraoperative solutions (frozen section and cytology) to prevent re-excision have not been adopted because they required a pathologist in the O.R., take too long during surgery, and only examine less than 1% of the tumor margin. Our long-term objective is to develop a chemically specific and quantitative multi-channel optical assay device for intraoperative assessment of tumor margins in patients undergoing breast conserving surgery (lump ectomy). The optical device will provide non-destructive evaluation of approximately 80% of the tumor margin in the excised specimen (as opposed to 1% provided by touch prep or frozen section); require no specialized personnel or sample processing (cutting and staining); and will require considerably less time than conventional techniques. The goal of the work is to design, fabricate and evaluate a single- channel alpha version of the optical assay device that will provide point measurements, and conduct a pilot clinical study on ex vivo breast tissues to demonstrate the feasibility and effectiveness of our novel technology. The specific aims are to: (1) design and optimize a single-channel optical device using Monte Carlo simulations; (2) build an alpha pro totype device based on the simulations, and (3) validate the device's performance against a standard bench- top optical system on synthetic breast tissue phantoms, and determine the sensitivity and specificity on excised human breast tissue specimens in a pilot clinical study. Concurrent with this effort, we are recruiting expertise in management, regulatory and reimbursement strategies so that we will be well positioned to bring this device to market following completion of the RandD program. This device w ill have significant clinical benefits including: (1) reduced repeat surgeries and hence, reduced local recurrence, (2) reduced tissue removal, which translates to cosmetically-superior lumpectomies at the time of the first surgery, (3) reduced emotional d istress, (4) reduced complications due to reduced number of surgeries and shorter recovery times for the patient and (5) reduced cost for the patient and the healthcare system. Successful completion of this project will set the foundation for the developme nt of a fast, multi-pixel optical assay system for intraoperative assessment of tumor margins in patients undergoing breast cancer surgery. The optical assay system will have significant clinical benefits including: (1) reduced re-excision rates, (2) reduc ed tissue removal, which translates to cosmetically-superior lumpectomies at the time of the first surgery, (3) better margin assessment leading to reduced repeat surgeries and hence, reduced local recurrence, (4) reduced emotional distress, and (5) reduce d complications due to reduced number of surgeries and shorter recovery times for the patient.

Principal Investigator:

Nimmi Ramanujam
9196605307
NIMMI@DUKE.EDU

Business Contact:


endlsoptics@gmail.com
Small Business Information at Submission:

ENDLS OPTICS CORPORATION
ENDLS OPTICS CORPORATION 2 Davis Drive Durham (RTP), NC 27709

EIN/Tax ID: 120511438
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Research Institution Information:
DUKE UNIVERSITY
DUKE UNIVERSITY
2200 W. Main St.
DURHAM, NC 27705 2680
RI Type: Nonprofit college or university