Phase I Amount
$1,000,000
Molecular Breast Imaging to Guide Early-Stage Patient Care Molecular Breast Imaging (MBI) will one day provide decision guidance for patient management without the need to perform a biopsy - that is without the need to cut out tissue that often is found to be normal. MBI's future benefit to women's health will obviate stressful watching and waiting periods of months, and will guide chemotherapy or surgery decisions toward optimized outcomes. A suspicious growth is often seen in conventional mammography by casting its shadow on film. However, often the shadow becomes inconspicuous in the background of dense but normal tissues. MBI forms images through a completely different process: drugs of trace amounts are taken up in the abnormal tissues, and then shine gamma-rays out to an imaging instrument located near the breast. These imaging drugs, also known as "biomarkers", can be selected to probe specific biological processes of immediate concern to the physician. For example, the aggressiveness or invasiveness of a tumor can be probed by a biomarker designed to specifically target cellular proliferation (i.e., the rate of cell division and tissue growth). Other biomarkers can "light up" tumors featuring specified hormone receptors or other identifying cellular features known to be associated with certain types of cancer. One of these processes, namely the metabolic rate of proliferative cellular functions, is probed by the imaging agent known as 99mTc-sestamibi ("MIBI" for short). This agent was associated with breast cancer in the 1990s through the use of an imaging instrument known as the "Anger camera". This device, which was designed in 1957, has flexible utility in imaging any organ (from prostate to brain) as well as whole bodies. Only in recent years has the Anger camera been specially designed for imaging of an organ, namely the heart. The current proposal describes another specially designed camera, the Molecular Breast Imager, which forms images using a new, dual-head solid state detector that is a distinct improvement over the 52-year old Anger method. This detector has been developed by the applicant institution, Gamma Medica- Ideas (GM-I, Northridge, CA) in collaboration with researchers at the Mayo Clinic. Clinical trials conducted by Dr. O'Connor of the Mayo Clinic (one of the investigators on this project) demonstrate results that are superior to mammography for women with dense breasts - i.e., those women in whom shadows are difficult to cast. Dr. O'Connor also has shown MBI to be very specific, that is, resulting in few "false positives" that would lead to worrisome yet normal biopsy. The current proposal describes a program run by Gamma Medica-Ideas and involving clinical research collaborations at the Mayo Clinic, Cedars-Sinai Medical Center, and Harbor-UCLA. The aims are to commercialize the dual-head MBI scanner, to strengthen the case for routine use of MIBI for well-defined populations of women, and to associate new biomarkers with patients and disease stage such that subsequent decisions are non-invasively guided by MBI results.
Public Health Relevance: Molecular Breast Imaging to Guide Early-Stage Patient Care Non-invasive molecular imaging promises to benefit breast cancer patient care while reducing costs and uncertainties. This will be achieved by the screening of selected, at-risk populations of women and providing definitive diagnosis and therapy guidance. We propose a commercialization program for a highly accurate instrument capable of imaging molecular imaging agents at the earliest, most treatable stage of breast cancer, thereby optimizing decision making toward improved and cost-effective outcomes
Public Health Relevance Statement: ****** IDENTIFIED AS NCI SBIR BRIDGE PROPOSAL ****** Project Narrative Molecular Breast Imaging to Guide Early-Stage Patient Care Non-invasive molecular imaging promises to benefit breast cancer patient care while reducing costs and uncertainties. This will be achieved by the screening of selected, at-risk populations of women and providing definitive diagnosis and therapy guidance. We propose a commercialization program for a highly accurate instrument capable of imaging molecular imaging agents at the earliest, most treatable stage of breast cancer, thereby optimizing decision making toward improved and cost-effective outcomes.
Project Terms: 99mTc-Hexamibi; 99mTc-Sestamibi; Anger; Awareness; Awarenesses; Benefits and Risks; Biological Function; Biological Process; Biopsy; Body Tissues; Brain; Breast; CZT; Cancer Patient; Cancer of Breast; Cell Function; Cell Growth in Number; Cell Multiplication; Cell Process; Cell Proliferation; Cell division; Cell physiology; Cellular Function; Cellular Physiology; Cellular Process; Cellular Proliferation; Chlorozotocyna; Clinic; Clinical; Clinical Evaluation; Clinical Research; Clinical Study; Clinical Testing; Clinical Trials; Clinical Trials Design; Clinical Trials, Unspecified; Collaborations; Collimation; Collimator; Computer Programs; Computer software; Conduct Clinical Trials; Cyanocobalamin; Cyanocobalamin (Vitatmin B12); D-Glucopyranose; DCNU; Data; Decision Making; Development; Devices; Diagnosis; Disease; Disorder; Documentation; Dose; Drugs; Economics; Encephalon; Encephalons; Engineering; Engineerings; Ensure; Feedback; Female Health; Film; Fluorescence; Funding; Future; Gamma Rays; Generalized Growth; Genital System, Male, Prostate; Goals; Growth; Head; Heart; Hormone Receptor; Hot Spot; Hot Spots (Area of Increased Mortality); Human Prostate; Human Prostate Gland; Image; Institution; Investigators; Isotopes; Lead; Lesion; Light; Literature; MMG; Malignant Tumor of the Breast; Malignant neoplasm of breast; Mammogram; Mammography; Marketing; Measurement; Mechanics; Medical center; Medication; Metabolic; Methods; Molecular; Molecular Analysis; Multi-Institutional Clinical Trial; Multi-center clinical study; Multi-center clinical trial; Multi-site clinical study; Multi-site clinical trial; Nervous System, Brain; Normal Tissue; Normal tissue morphology; Operation; Operative Procedures; Operative Surgical Procedures; Organ; Outcome; Outcomes Research; Patient Care; Patient Care Delivery; Patients; Pb element; Performance; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Photoradiation; Physicians; Population; Populations at Risk; Process; Programs (PT); Programs [Publication Type]; Prostate; Prostate Gland; Prostatic Gland; Radiation; Radiation, Gamma; Recovery; Reporting; Research; Research Design; Research Personnel; Research, Outcomes; Researchers; Resolution; Risk; Running; SBIR; SBIRS (R43/44); SCHED; Scanning; Schedule; Screening procedure; Shadowing; Shadowing (Histology); Small Business Innovation Research; Small Business Innovation Research Grant; Software; Specific qualifier value; Specified; Spottings; Staging; Standardization; Study Type; Subcellular Process; Surgical; Surgical Interventions; Surgical Procedure; System; System, LOINC Axis 4; Task Performances; Tc 99m Sestamibi; Tc MIBI; Tc-99m MIBI; Tc-99m-Methoxy-2-isobutylisonitrile; Tc99m Sestamibi; Technetium Tc 99m 2-Methoxy-2-methylpropylisonitrile; Technetium Tc 99m Sestamibi; Technetium(1+)-99Tc, hexakis(1-isocyano-2-methoxy-2-methylpropane)-, (OC-6-11)-; Technetium-99m-Hexamibi; Technetium-99m-Sestamibi; Technology; Thallium; Thick; Thickness; Time; Tissue Growth; Tissues; Tl element; Translating; Translatings; Uncertainty; VIT B12; Vitamin B 12; Vitamin B12; Woman; Women's Health; angers; angry; base; biomarker; cancer type; chemotherapy; chlorozotocin; clinical investigation; clinical test; commercialization; computer program/software; cost; design; designing; detector; disease/disorder; dissemination trial; doubt; drug/agent; flexibility; heavy metal Pb; heavy metal lead; high risk; imaging; imaging probe; improved; innovate; innovation; innovative; instrument; language translation; malignant breast neoplasm; molecular imaging; multi center clinical study; multi center clinical trial; multi site clinical study; multi site clinical trial; ontogeny; product development; programs; prototype; public health relevance; ray (radiation); research clinical testing; screening; screenings; solid state; study design; success; surgery; tumor; vitamin B12 compound
