Transforming Mammography With STARLIGHT, Imagine Scientific's Monochromatic X-Ray Imaging System

Transforming Mammography With STARLIGHT Imagine Scientific's Monochromatic X-Ray Imaging System ABSTRACT Imagine Scientific has invented the first and only practical, IP-protected, cost effective, high power monochromatic X-ray source with short exposure times for diagnostic imaging in the clinic. This long-awaited breakthrough for radiology is called STARLIGHT, which provides an extensive range of selectable monochromatic energies with sufficient intensity and beam coverage for many radiological imaging procedures. Its initial application for commercial development is as an X-ray source for mammography. STARLIGHT offers (i) superior detection of tumors for all women, including those with thick and dense breasts, (ii) significantly lower radiation dose, and (iii) elimination of painful breast compression during examinations. Invasive breast cancer, the most common cancer in women, affects 1 in 8 US women. Over 260,000 new cases are diagnosed annually and over 40,000 women die each year, mostly those diagnosed with advanced stage cancer. Though mammography detects cancer in ~ 85% for women with low breast density (BI-RAD categories 1 and 2), screening is much less effective (48%-64%) for the 40%-50% of women who have dense breasts (BI-RAD categories 3 and 4), increasing their risk of developing cancer as much as 4 to 6 times. STARLIGHT addresses unmet women’s healthcare needs caused by the performance limitations of current mammography systems. A mammography machine using monochromatic X-rays will have higher sensitivity and specificity than conventional mammography, yielding better detection of cancers while considerably lowering false-positive findings, potentially preventing the costs and high stress of unnecessary biopsies,and referrals for adjuvant ultrasound and MRI scans. In addition to a more conclusive diagnosis, women screened with STARLIGHT-based mammography systems will receive considerably lower radiation dose and findings based on industry-standard phantom measurements in the Imagine Scientific laboratory suggest the STARLIGHT system also reduces the painful breast compression experienced with conventional mammography. Monochromatic mammography’s superior performance has the huge potential to improve detection sensitivity at a lower radiation dose for early-stage cancers in the ~45 million women screened each year (US) and substantially reduce morbidity associated with misdiagnosed or late-diagnosed breast cancer. STARLIGHT is the first, high power monochromatic X-ray source for diagnostic imaging in the clinic. It delivers sufficient monochromatic X-ray emission in a pulse, enabling the short exposure times required for 2-D full-field mammography (FFDM) and 3-D digital breast tomosynthesis (DBT). STARLIGHT can be integrated into conventional 2-D and 3-D mammography systems, which means no physical modifications are needed in breast imaging centers. Furthermore, using monochromatic X-rays does not require changes in clinical workflow and operating procedures. The cost to manufacture a STARLIGHT X-ray source is similar to current conventional x- ray sources used for mammography. In Year 1, Imagine Scientific will complete the fabrication of two commercial-grade versions of STARLIGHT for installation in commercial mammography systems. Together with collaborators from the Massachusetts General Hospital (MGH) and the University of California at San Diego (UCSD), the team will use one instrument to show superior image quality and lower radiation doses compared to current mammography systems in a series of 2-D and 3-D tests with industry phantoms. In Year 2, it will use the second unit in a dedicated clinical trial at Duke University Medical Center to demonstrate specific and important clinical benefits of monochromatic imaging. We will continue to develop a collaborative manufacturing and marketing plan with Varex Imaging Corporation while concurrently refining and testing STARLIGHT at Imagine Scientific. Project Number: 1R44CA302210-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Eric Silver | Institution: IMAGINE SCIENTIFIC, INC., Norwood, MA | Award Amount: $779,658 | Activity Code: R44 | Study Section: Special Emphasis Panel[ZCA1 RTRB-S (M2)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11255902