SBIR-STTR Award

Early detection of breast cancer is a primary goal in cancer imaging and it is important to identify tumors at an early stage of growth to identify their type. Standard x-ray mammography does not always provide adequate diagnosis; e.g., in cases such as dense or radiation-scarred breasts, and often does not identify tumor presence until significant growth has occurred. Alternative methods are being developed to circumvent these problems, including MRI, ultrasound, scintigraphy, and other methods. A novel method using biomagnetic sensors to detect superparamagnetic particles targeted to tumors is described here. This technique takes advantage of a large amount of research into the use of nanoparticles containing ferric cores and coated with various agents which target tumors either through their dense vascularization or through specific antibodies. Standard biomagnetic sensors using Superconducting Quantum Interference Devices (SQUID) are capable of detecting nanograms of such materials. Research into the use of such nanoparticles, referred to as ultra-small particles of iron oxide (USPIO) indicate that this quantity is easily deliverable to tumor sites with injections orders-of-magnitude below tolerance levels and with significant tumor-to-normal tissue density ratios. This Phase I study has the specific aims of (1) constructing a breast phantom with small inclusions of USPIO agents of various types, (2) measuring the magnetic fields of magnetized USPIO inclusions in this phantom, (3) provide a preliminary design of a biomagnetic sensor system specifically for breast cancer imaging, and (4) design optimal methods for magnetizing the superparamagnetic nanoparticles whether bound in a tumor by antibodies or in microvessels of tumor vascular structure.

Thesaurus Terms:
biomagnetism measurement, biomedical equipment development, breast neoplasm /cancer diagnosis, diagnosis design /evaluation, model design /development, phantom model, superconductivity magnetic field, nanotechnology bioengineering /biomedical engineering

The principal objective of this application is to establish a new methodology for the early detection of abnormal lesions, whether pre-cancerous or cancerous, in breast imaging. Early detection is crucial to identifying lesions while they are still contained when the cure rate is near 100%. Existing mammography often does not identify lesions until significant growth has occurred. Because of the importance of the problem, there is research in alternative methods, including MRI, ultrasound, scintigraphy, and other methods. We propose here, a novel approach using biomagnetic sensors and targeted superparamagnetic nanoparticles. The sensor will detect and image lesions in-vivo to which these particles have bound by antibodies or angiogenesis agents after injection into the subject. We have demonstrated in Phase I of this program, that Superconducting Quantum Interference Devices (SQUID) are capable of detecting sub- nanograms of these nanoparticles. This methodology has advantages over existing mammography in the flexibility of nanoparticle choices to increase specificity through antibodies targeting cancer types such as HER-2, and angiogenesis agents targeting tumor microvascular structure. Nanoparticles will also be used to image sentinel cells for metastases. We will use phantoms and tissue preparations to characterize nanoparticles for sensitivity and image capabilities and animal studies to verify the methodology. We will further affirm imaging accuracy through the use of these nanoparticles as contrast agents in MRI studies in our animal studies. We anticipate that the detection of lesions by magnetic sensors will provide a lower false positive rate than mammograms and, more importantly, a higher true positive rate.

Thesaurus Terms:
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