SBIR-STTR Award

Early diagnosis and early treatment of cancer greatly improve the likelihood of long-term survival and health. Chemical structures that are selectively taken by cancerous tissue can be used to pull diagnostic and therapeutic moieties to cancerous tissue. Appropriately sized iron and/or iron oxide nanoparticles are effective for both diagnosis (via magnetic resonance imaging, MRI) and therapy (by hyperthermal methods). But they tend to clump into ineffective sizes, and they distribute among healthy tissue, making them of little value for diagnosis or treatment. NanoScale Corporation, with its partners at Kansas State University, propose synthesis of "stealth" Fe/Fe3O4 core/shell nanoparticles that are encapsulated, to prevent agglomeration, and that contain carefully selected functional groups that will localize in cancer tissues. The team will evaluate these stealth nanoparticles for physical properties such as MRI relaxivity and hyperthermal potential, and for adhesion to cancer cells. Finally, in vivo experiments with tumor-bearing mice will confirm the feasibility of stealth Fe/Fe3O4 core/shell nanoparticles for cancer diagnosis and treatment. NanoScale has extensive experience in synthesis, manufacture, and characterization of metal and metal oxide nanoparticles. Prof. Stefan Bossman is internationally recognized for his accomplishments in linking diagnostic and therapeutic groups to bioactive structures.

NIH Spending Category:
Bioengineering; Cancer; Diagnostic Radiology; Nanotechnology

Project Terms:
Adhesions; Animal Model; Animal Models and Related Studies; Body Tissues; Cancerous; Cancers; Chemical Structure; Diagnosis; Diagnostic; Early Diagnosis; Early treatment; Encapsulated; Fe element; Health; Iron; Kansas; Link; MR Imaging; MR Tomography; MRI; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Malignant Cell; Malignant Neoplasms; Malignant Tumor; Mammals, Mice; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Metals; Methods; Mice; Murine; Mus; NMR Imaging; NMR Tomography; Nuclear Magnetic Resonance Imaging; Porphyrins; Powder dose form; Powders; Series; Testing; Therapeutic; Tissues; Tumor Tissue; Universities; Zeugmatography; cancer cell; cancer diagnosis; colcothar; design; designing; early detection; experience; experiment; experimental research; experimental study; ferric oxide; functional group; improved; in vivo; iron oxide; malignancy; metal oxide; model organism; nano device; nano meter scale; nano meter sized; nano particle; nano scale; nano sized; nanodevice; nanodevices; nanometer scale; nanometer sized; nanoparticle; nanoscale; nanosized; neoplasm/cancer; physical property; prevent; preventing; red iron oxide; research study; tumor

Early diagnosis and treatment of cancer greatly improve the likelihood of long-term survival and health. In Phase I, NanoScale Corporation and its partners at Kansas State University developed functionalized cancer-seeking "stealth" Fe/Fe3O4 core/shell nanoparticles, and demonstrated their feasibility for diagnosis of cancer by optical imaging. In Phase II, the NanoScale/KSU team will optimize the nanoparticles for diagnosis of breast cancer by fluorescence optical imaging, giving the surgeon an immediate technique for identifying the tumor margin. A maximum Tolerated Dose study, including a Repeat Dose phase, will evaluate toxicity in rats. An Ames test will evaluate mutagenic potential. Ex vivo studies with excised breast tumor specimens will determine the ability of the functionalized nanoparticles to improve margin identification. A Clinical Study Report will be prepared, and discussed with FDA personnel in a pre-IND meeting. Strategic alliances with recognized diagnostic/imaging companies will be established. NanoScale has extensive experience in synthesis, manufacture, and characterization of metal and metal oxide nanoparticles. Professors Stefan Bossmann and Deryl Troyer are internationally recognized for their accomplishments in synthesizing and evaluating anti-cancer compounds. Dr. Mark Cohen, surgical oncologist, is an expert in evaluating novel targeted therapies. Dr. Scott Weir has great experience in drug development and registration.