SOLICITATION NOTICE
B -- Ultrasound Study of Tamoxifen: Ultrasound Image Analysis
- Notice Date
- 8/15/2011
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-110155-MW
- Archive Date
- 9/14/2011
- Point of Contact
- Melissa R. Ward, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
wardmr@mail.nih.gov, cr214i@nih.gov
(wardmr@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Room 6074, Rockville, MD, 20852, UNITED STATES Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB) plans to procure on a sole source basis the analysis of ultrasound tomography breast imaging scans from the Wayne State University, 4100 John R., Detroit, MI 48201. The services herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 541690 and the business size standard is $7.0M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of Performance shall be a base year of twelve (12) months from date of award, with an additional twelve (12) month option period. Elevated mammographic breast density is the strongest risk factor for sporadic breast cancer apart from age. Emerging data from several prospective studies suggest that changes in breast density are positively related to changes in breast cancer risk. Along these lines, successful chemoprevention with tamoxifen use has been linked to a decline in breast density by ~10% or more at 12-18 months, suggesting that breast density change may be a "biosensor" of treatment effectiveness. To date, detection of density changes has been limited by properties of mammography including: 1) two-dimensional representation of a three-dimensional organ; 2) need for compression which distorts tissue architecture and varies between examinations; 3) over-estimation of density, especially among women with denser breasts; and 4) ionizing radiation exposure, which raises concerns about risks related to repeated assessments. Ultrasound tomography is ideally and uniquely suited for measuring breast density and changes in density. Wayne State University, and its affiliate, the Karmanos Cancer Institute, has developed an ultrasound tomography (UST) method, and constructed a clinical prototype which is housed in its breast center and is dedicated for research purposes. UST is ideal for assessing breast density repeatedly, painlessly, reliably, and volumetrically, without exposure to potentially harmful ionizing radiation. UST, like an MRI permits assessment of density patterns spatially within the breast at baseline and at follow-up exams, while avoiding many of the limitations of mammography. Compared with MRI, UST is much less costly, faster to perform and does not require placement in a specially shielded room. UST examination calculates sound speed within the breast, an objective physical measurement that is directly related to tissue density. Sound speed is fixed to an external standard, and is thereby relatively unaffected by day-to-day performance factors, whereas mammographic density assessment is operator and machine dependent. Consequently, UST measurements may provide a more accurate and reproducible measure of breast tissue density. The purpose of this procurement is to conduct breast ultrasound tomography (UST) image analysis in order to define the time course of volumetric breast density changes that are associated with tamoxifen treatment. This image analysis will support a new observational study developed by NCI, in which participants will be enrolled over the course of a two-year field effort and followed at the Karmanos Cancer Institute. UST will be used to repeatedly assess volumetric breast density within the first year of tamoxifen monotherapy for 150 women. The NCI will assess whether the decline in mammographic density found at 12 months can be identified earlier with UST. For comparison, UST will be performed on a group of 150 age-, race-, and menopausal status-matched women without breast cancer in order to assess changes in UST density over time without tamoxifen exposure. The broader study objective is to assess the concept of breast density as a biosensor of tamoxifen response and UST as a useful tool for making this determination. Under the guidance of Dr. Neb Duric, Professor, Department of Radiation Oncology, the UST prototype and related analytical algorithms developed at Wayne State University (WSU) and its affiliate, the Karmanos Cancer Institute (KCI) represents the only approach for measuring density using sound speed. Currently available technologies for measuring density that are widely used clinically are technically limited. Mammographic density is limited by its reliance on a two-dimensional image and its variation with instrumentation, settings and breast compression. Furthermore, mammography exposes the breast to ionizing radiation which may itself increase cancer risk and requires precautions to protect medical personnel; therefore, it is unsuitable for performing short interval repeat examinations such as those included in this study. Magnetic resonance imaging can provide a volumetric density measurement, but it is an expensive technique that requires substantial expertise and special housing to limit exposure to magnetic fields. The ultrasound tomography method used at WSU is suitable for performing closely timed repeated examinations without substantial risk. The device does not require breast compression and provides a three-dimensional tomographic image of breast parenchyma. The device provides an objective quantitative measurement of a physical quantity, sound speed, with demonstrated correlations with breast density. The device achieves excellent precision such that comparisons across serial examinations performed over time can be used to distinguish density changes related to tamoxifen from random fluctuations. The UST prototype and related analytical algorithms developed at WSU/KCI represent the only approach for measuring breast density using sound speed, and therefore this organization is uniquely qualified to perform the analysis under this procurement. This notice is not a request for a competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Capability statements must be received in the contracting office by 11:00 AM EST, on August 30, 2011. For further information, please contact Melissa Ward, Contract Specialist via electronic mail at Melissa.Ward@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference: NCI-110155-MW on all correspondence.
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