IMAGING NETWORK FOR BREAST CANCER MASS SCREENING

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,220,062.00
Award Year:
2004
Program:
SBIR
Phase:
Phase II
Contract:
2R44CA091392-02A2
Award Id:
53857
Agency Tracking Number:
1R43CA091392-01
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
ARTANN LABORATORIES, INC., 1457 LOWER FERRY RD, TRENTON, NJ, 08618
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
ARMEN SARVAZYAN
(609) 333-0710
armen@artannlabs.com
Business Contact:
ARMEN SARVAZYAN
(609) 883-0100
ARMEN@ARTANNLABS.COM
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Early detection of breast cancer remains one of the most significant challenges in health care. The tactile breast imager (TBI) is a promising solution that electronically captures the sense of touch to provide a quantitative, sensitive, and permanent record of palpatory breast examination. Its inherent low cost, ease of use, and promising test results to date, give it great potential as an effective mass pre-screening tool for breast cancer detection. In Phase I, we successfully developed and tested a prototype device that showed sensitivity well beyond the manual palpation limit in a variety of test conditions. The device was tested on physical tissue models and demonstrated to robustly detect nodules of various sizes and subcutaneous depths. Advanced data processing algorithms were developed providing vivid 3-D images of the underlying mechanical tissue structure. In Phase II we will perform an initial clinical study to acquire raw image data and correlated lesion mechanical property data for use in refining the image processing and feature identification capabilities. We will concurrently build an advanced TBI prototype with substantially improved sensor performance. Clinical studies will be performed involving concurrent mammography / TBI imaging with qualitative comparative analysis between the modalities. We will conduct clinical development studies and build physical breast models to improve the data collection and lesion discrimination performance. The TBI will then be tested in a blinded clinical study to obtain statistically relevant measures of lesion sensitivity, specificity, and mechanical image quality. Appropriate regulatory testing will be conducted in order to prepare necessary engineering documentation for a FDA application.

* information listed above is at the time of submission.

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