The focus of this proposal is the development of a novel in-vivo imaging device (Molecular Breast Imaging system) that incorporates a clinical validation experiment and a limited pilot and a clinical feasibility evaluation for pre-clinical and clinical studies. Our primary intent is to facilitate the proof of feasibility of this novel imaging device for early detection, diagnosis, and treatment monitoring of breast cancer. The purpose of this imaging system is to define the characteristics of breast cancer at a molecular level using both established and novel radioactive markers that can enable the early detection and monitor the treatment of breast cancer. The novelty of this system is two fold: 1) development of a system that will comprise two opposing Cadmium Zinc Telluride (CZT) semi-conductor detectors in a specialized gantry, and 2) development of algorithms and corresponding clinical software packages that will permit absolute quantitation of tumor uptake of radiopharmaceuticals and permit monitoring of the kinetics of uptake and washout of radiopharmaceuticals in breast tissue. It is our primary goal in this Fast Track STTR proposal to create clinical tools, dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (Mayo) for functional breast imaging. Our secondary goal is demonstrate the ability of the camera to be utilized as a preclinical research device. Each facility will complete small patient trials to illustrate the potential application of this device and associated software in the evaluation of new radiopharmaceuticals for detection of breast cancer. During the Phase I of this Fast Track STTR we will construct a fully functional Dual Headed CZT breast imaging camera complete with Acquisition, Processing, Tumor Quantification, and simultaneous dual Isotope Capabilities. One tested prototype camera will be built during Phase-I and two additional cameras will emulate the original and their assembly will take place during Phase-II. During Phase-II of this proposal the primary goal is to evaluate the clinically usefulness of a dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (to be developed by Mayo). This will be accomplished through a multi-center pilot study. Three sites will conduct a patient study that will validate the ability of this device to detect sub-10 mm breast lesions. The secondary goals are 1) to compare the diagnostic capabilities of this device to MRI, 2) to explore the potential application of this device in dual-isotope studies, and 3) to demonstrate its ability to evaluate new promising radiopharmaceuticals. The secondary goals will be accomplished during Phase II and will be undertaken at all three clinical sites. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
4R42CA128407-02
Application #
7678779
Study Section
Special Emphasis Panel (ZRG1-SBMI-S (10))
Program Officer
Evans, Gregory
Project Start
2007-09-30
Project End
2010-08-31
Budget Start
2008-09-22
Budget End
2009-08-31
Support Year
2
Fiscal Year
2008
Total Cost
$862,390
Indirect Cost
Name
Gamma Medica-Ideas, Inc.
Department
Type
DUNS #
105889286
City
Northridge
State
CA
Country
United States
Zip Code
91324
O'Connor, Michael K (2015) Molecular breast imaging: an emerging modality for breast cancer screening. Breast Cancer Manag 4:33-40
Hruska, Carrie B; O'Connor, Michael K (2013) Nuclear imaging of the breast: translating achievements in instrumentation into clinical use. Med Phys 40:050901
Swanson, Tiffinee N; Troung, Duong T; Paulsen, Andrew et al. (2013) Adsorption of 99mTc-sestamibi onto plastic syringes: evaluation of factors affecting the degree of adsorption and their impact on clinical studies. J Nucl Med Technol 41:247-52
Weinmann, Amanda L; Hruska, Carrie B; Conners, Amy L et al. (2013) Collimator design for a dedicated molecular breast imaging-guided biopsy system: proof-of-concept. Med Phys 40:012503
Mitchell, David; Hruska, Carrie B; Boughey, Judy C et al. (2013) 99mTc-sestamibi using a direct conversion molecular breast imaging system to assess tumor response to neoadjuvant chemotherapy in women with locally advanced breast cancer. Clin Nucl Med 38:949-56
Hruska, Carrie B; Weinmann, Amanda L; Tello Skjerseth, Christina M et al. (2012) Proof of concept for low-dose molecular breast imaging with a dual-head CZT gamma camera. Part II. Evaluation in patients. Med Phys 39:3476-83
Hruska, Carrie B; Weinmann, Amanda L; O'Connor, Michael K (2012) Proof of concept for low-dose molecular breast imaging with a dual-head CZT gamma camera. Part I. Evaluation in phantoms. Med Phys 39:3466-75
O'Connor, Michael K; Li, Hua; Rhodes, Deborah J et al. (2010) Comparison of radiation exposure and associated radiation-induced cancer risks from mammography and molecular imaging of the breast. Med Phys 37:6187-98
Weinmann, Amanda L; Hruska, Carrie B; O'Connor, Michael K (2009) Design of optimal collimation for dedicated molecular breast imaging systems. Med Phys 36:845-56
O'Connor, Michael; Rhodes, Deborah; Hruska, Carrie (2009) Molecular breast imaging. Expert Rev Anticancer Ther 9:1073-80