Project Grant R44CA268468

STARLIGHT, THE NEXT GENERATION X-RAY IMAGING TECHNOLOGY - STARLIGHTTM, THE NEXT GENERATION X-RAY IMAGING TECHNOLOGY ABSTRACT IMAGINE SCIENTIFIC HAS INVENTED STARLIGHT, AN IP-PROTECTED MONOCHROMATIC X-RAY SOURCE THAT WILL SIGNIFICANTLY IMPROVE MEDICAL IMAGING. IT IS A LONG-AWAITED ENGINEERING AND SCIENTIFIC BREAKTHROUGH, AND THE FIRST PRACTICAL, COST-EFFECTIVE, CLINICAL SOURCE OF MONOCHROMATIC X-RAYS FOR DIAGNOSTIC IMAGING. IN ITS FIRST CLINICAL APPLICATION, IT WILL BE USED IN X-RAY MAMMOGRAPHY TO CONSIDERABLY ADVANCE SCREENING AND DIAGNOSIS OF BREAST CANCER. MAMMOGRAPHY SYSTEMS USING STARLIGHT WILL OFFER (I) SUPERIOR DETECTION OF TUMORS FOR ALL WOMEN, INCLUDING THOSE WITH THICK AND DENSE BREASTS, (II) SIGNIFICANTLY LOWER RADIATION DOSE, (III) ELIMINATION OF PAINFUL BREAST COMPRESSION DURING EXAMINATIONS, AND (IV) CHEMICAL ANALYSIS OF TISSUE IN-VIVO. BREAST CANCER IS THE MOST COMMON CANCER IN WOMEN, WITH OVER 260,000 NEW CASES DIAGNOSED EACH YEAR IN THE US. 1 IN 8 WOMEN WILL DEVELOP INVASIVE BREAST CANCER DURING THEIR LIFETIME. 40%-50% OF WOMEN HAVE DENSE BREASTS (BI-RAD CATEGORIES 3 AND 4 - HIGH PROPORTION OF GLANDULAR AND FIBROUS TISSUE), INCREASING THEIR RISK OF DEVELOPING CANCER BY 4 TO 6 TIMES. THE DETECTION SENSITIVITY LEVEL FOR THESE WOMEN IS 48%-64%, COMPARED TO ~ 85% FOR WOMEN WITH LESS GLANDULAR AND LOW AMOUNTS OF FIBROUS BREAST TISSUE (BI-RAD CATEGORIES 1 AND 2). STARLIGHT ADDRESSES UNMET WOMEN'S HEALTH NEEDS CAUSED BY THE PERFORMANCE LIMITATIONS OF CURRENT MAMMOGRAPHY SYSTEMS. MAMMOGRAPHY SYSTEMS USING MONOCHROMATIC X-RAYS WILL IMPROVE DETECTION SENSITIVITY FOR EARLY-STAGE CANCERS IN THE ~45 MILLION WOMEN SCREENED EACH YEAR (US). HIGHER SENSITIVITY WILL REDUCE THE NUMBER OF MISSED DIAGNOSES OF CANCER, WHILE HIGHER SPECIFICITY WILL CONSIDERABLY LOWER THE NUMBER OF FALSE POSITIVE CANCER DETECTIONS AND THE UNNECESSARY RESULTING BIOPSIES, REFERRALS FOR ADJUVANT ULTRASOUND AND MRI SCANS, AND AVOIDABLE COSTS AND HIGH STRESS LEVELS FOR AFFECTED PATIENTS. IN ADDITION TO A MORE CONCLUSIVE DIAGNOSIS, WOMEN SCREENED WITH STARLIGHT-BASED MAMMOGRAPHY SYSTEMS WILL RECEIVE CONSIDERABLY LOWER RADIATION DOSE AND EXPERIENCE BREAST EXAMS WITHOUT UNDERGOING PAINFUL BREAST COMPRESSION. MONOCHROMATIC MAMMOGRAPHY'S SUPERIOR PERFORMANCE IS EXPECTED TO SUBSTANTIALLY REDUCE MORBIDITY ASSOCIATED WITH MISDIAGNOSED OR LATE-DIAGNOSED BREAST CANCER. STARLIGHT IS THE FIRST TECHNOLOGY CAPABLE OF PRODUCING SELECTABLE, MONOCHROMATIC X-RAYS WITH THE REQUIRED INTENSITY FOR FULL-FIELD MAMMOGRAPHY AND CAN BE INTEGRATED INTO CONVENTIONAL 2-D AND 3-D MAMMOGRAPHY SYSTEMS. THE COST TO MANUFACTURE A STARLIGHT-BASED MAMMOGRAPHY SYSTEM IS EXPECTED TO BE SIMILAR TO CURRENT COMMERCIAL MACHINES. IMAGINE SCIENTIFIC WILL DESIGN, FABRICATE AND BUILD AN ADVANCED STARLIGHT MONOCHROMATIC X-RAY SOURCE WITH AT LEAST 10 TIMES THE INTENSITY OF THE CURRENT PROTOTYPE, ENABLING EXPOSURE TIMES BETWEEN 1 AND 7 SECONDS. IT WILL BE INSTALLED IN A COMMERCIAL MAMMOGRAPHY SYSTEM, TO DEMONSTRATE SUPERIOR IMAGE QUALITY AND LOWER RADIATION DOSES COMPARED TO CURRENT MAMMOGRAPHY SYSTEMS.