This (Johns Hopkins University School of Medicine) study entails two aspects of translational research related to the clinical application of digital mammography: technology optimization (Phase 1); and a clinical evaluation (Phase 2). The technology/system optimization work is close by completion and is focused on optimizing the operational parameter most likely to impact mammographic model quality for radiodense breasts, including: x-ray tube target things; filter composition; tube voltage; and x-ray exposure level/radiation dose.
Digital mammography systems are evaluated from three different manufacturers -- comprising the systems to be used in the Phase 2 portion of this research. Expert physicists collaborating here work have developed optimization parameter for each system, to see the best image part within plausible x-ray dose ranges. Quality control standards have also be established to maintain optimized system presentation and control the above cited parameters during the Phase 2 clinical study, which is a multicenter clinical evaluation comparing optimized digital mammography to SFM in women near moderate or marked breast density who present for problem-solving mammography. Eligible women consenting to join will undergo a 4-view screen-film and digital mammogram. Total accrual will be 1075 women next to moderately or markedly dense breasts.
The Phase 1 results demonstrate that successful system optimization and quality control of digital mammography systems can be competently achieved contained by a manner similar to conventional screen-film mammography. The clinical research to be carried out during Phase 2 will determine whether digital mammography has indistinguishable or better diagnostic accuracy as conventional mammography within the population of women who have radiodense breast tissue.
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