SPECIAL NOTICE
66 -- Request for Information (RFI): Ultrasound Tomography Device to Assess Sound Speed as a Measurement of Breast Tissue Density
- Notice Date
- 6/10/2010
- Notice Type
- Special Notice
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- 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
- RFI-NCI-100107-TG
- Archive Date
- 7/10/2010
- Point of Contact
- Terry Galloway, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
gallowaytl@mail.nih.gov, cr214i@nih.gov
(gallowaytl@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: This Request for Information (RFI) is intended to provide source material for a state-of-the science summary of technology and methodology available for performing ultrasound tomography of the breast with validated technically supported algorithms to measure sound speed as a measure of breast tissue density. The unit should be associated with a clinical research program that performs mammographic screening of a racially diverse under-served population. This RFI should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the NCI. The NCI does not intend to award a cooperative agreement, grant, or contract on the basis of responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. Purpose: The responses to this RFI may guide the NCI in awarding future contracts at an undetermined time to conduct epidemiological translational research related to assessment of breast density. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME; no basis for claims against NCI shall arise as a result of a response to this Request for Information notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. This notice is for market research only. The NCI is specifically interested in determining the types of organizations available in the marketplace that provide these technologies. In particular, the NCI is seeking qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB) which provide these technologies]. Based on the responses received from this announcement, an acquisition may be solicited as a Total Small Business Set-Aside. NAICS Code and Size Standard: In the event a Request for Quotation (RFQ) is issued, North American Industry Classification System (NAICS) code 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing with a size standard of 500 employees is being considered. Background: The Division of Cancer Epidemiology and Genetics (DCEG) has a longstanding interest in breast cancer epidemiology, including risk assessment, breast imaging and radiology, assessment of breast biology and translational and management issues related to breast cancer, including its prevention, detection and treatment. Breast density has emerged as one of the strongest identified independent risk factors for breast cancer, apart from age and gender. Density is a modifiable risk factor. Notably, drugs such as tamoxifen, which are effective in both treatment and prevention of breast cancer, are known to reduce breast density. 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 testing younger women or performing short interval repeat examinations for research. 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. Accordingly, we wish to assess the availability of low-frequency ultrasound technology devices that are suitable for assessing young women and for performing closely timed repeated examinations without substantial risk. The device should not require breast compression and must provide three-dimensional tomographic images of breast parenchyma. The device should provide an objective quantitative measurement of a physical quantity such as sound speed, which is correlated with breast density. Finally, the device must achieve excellent precision such that comparisons across serial examinations performed over time can be used to distinguish density changes related to specific interventions from random fluctuations. Information Requested: I. General Information - contact information, including name, institution / organization, telephone and fax numbers and e-mail address; website URL II. Equipment, software, and system capabilities requirements Information is sought regarding ultrasound tomography devices for breast imaging that reliably measure tissue density as a physical parameter such as sound speed. The device must be installed in a clinical research environment that performs mammographic screening of a racially diverse under-served population and should have been validated by comparison to other techniques for measuring breast density. The NCI seeks information regarding the following: Ultrasound tomography devices for breast imaging with the following characteristics: 1. Automated scanning of the breast from chest wall to nipple; 2. Low-frequency ultrasound waves (e.g., <2 MHz) with a short exposure time (e.g., <2 minutes) that do not pose a threat to health of patients or medical personnel working in proximity to the apparatus; 3. Easily operable with minimal training; 4. Capable of producing three-dimensional breast images interpretable by radiologists or others with expertise in interpretation of breast images; 5. Performance data related to detection of breast masses; 6. Supported by algorithms for calculation of sound speed as an objective quantitative measure of breast tissue density; 7. Validation of ultrasound measurements by demonstrating correlation of volume averaged sound speed throughout the breast to percent mammographic density estimated as an area using validated methods applied to film and digital mammograms; 8. Validation of ultrasound measurements by demonstrating correlation of volume averaged sound speed throughout the breast to volumetric assessments of tissue composition based on magnetic resonance imaging; 9. Evidence that device achieves good precision with repeated testing; 10. Strong technical support for application of analytical algorithms; 11. At least anecdotal evidence of use to assess changes in density in response to clinical interventions such as administration of drugs for treatment or prevention of breast cancer. Please provide information regarding the location of the ultrasound tomography device and the demographics of the population where the device is used. Access to a clinical facility using this ultrasound tomography device is required. The clinical facility should have the following characteristics: 1. Physical proximity to a mammographic breast imaging center; 2. Performs mammographic breast cancer screening in a racially diverse under-served population; 3. Related to a clinical research unit that includes experienced study coordinators, physicians with translational research experience and interests and supported by scientists with expertise in ultrasound technology, radiology and analytical algorithms for computing sound speed and breast density; 4. Demonstrated capacity to recruit study subjects, including minority subjects, to participate in studies requiring interviews, donation of biological specimens and radiological examinations; 5. Interaction with a pathology department that can support research including collection of fixed and frozen breast tissues for investigational assays. Additional comments relevant to this RFI, and addressing issues that are not specifically mentioned above, are also encouraged. How to Submit a Response: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single space, 12 point font minimum) that clearly details the ability to perform the aspects of the notice described above. Brevity and structured format (such as bulleted items) are encouraged whenever applicable to aid in processing. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NCI personnel and will be held in a confidential manner. Due Date: Capability statements are due no later than June 25, 2010 11:00 am Eastern Time Number of Copies and Delivery Point: Please submit one (1) original and three (3) copies of your response as follows: If hand-delivered, delivery service or using U.S. Postal Service: Terry Galloway, Contract Specialist 6120 Executive Blvd., Room 6068 Rockville, MD 20852-7194 All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Terry Galloway, Contract Specialist, at terry.galloway@nih.gov. A determination by the Government not to compete this 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. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference number RFI-NCI-100107-TG on all correspondence. Point of Contact: Inquiries concerning this Notice may be directed to: Terry Galloway 6120 Executive Boulevard, Room 6068 Rockville, MD 20852 terry.galloway@nih.gov
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