Clinical Evaluation of Digital Mammography
Abstract
Our 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 near completion and has focused on optimizing the operational parameters most likely to impact mammographic image quality for radiodense breasts, including x-ray tube target material, filter composition, tube voltage, and x-ray exposure level/radiation dose. We have evaluated digital mammography systems from 3 different manufacturers - comprising the systems to be used in the Phase 2 portion of this research. Expert physicists collaborating in this work have developed optimization parameters for each system to enable the best image quality within reasonable x-ray dose ranges. In addition, quality control standards have also been established to maintain optimized system performance and control the above cited parameters during the Phase 2 clinical study. The second phase of this project is a multicenter clinical evaluation comparing optimized digital mammography to SFM in women with moderate or marked breast density who present for problem-solving mammography. Eligible women consenting to participate will undergo a 4-view screen-film and digital mammogram. Total accrual will be 1075 women with moderately or markedly dense breasts. The clinical trial is scheduled to open July 1,2000. Our Phase 1 results demonstrate that successful system optimization and quality control of digital mammography systems can be efficiently achieved in a manner similar to conventional screen-film mammography. The clinical research to be carried out during Phase 2 will determine whether digital mammography has the same or better diagnostic accuracy as conventional mammography in the population of women who have radiodense breast tissue.
Document Details
- Document Type
- Technical Report
- Publication Date
- Feb 01, 2000
- Accession Number
- ADA382368
Entities
People
- Laurie L. Fajardo
Organizations
- Johns Hopkins University