The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines

Abstract

In this article, we trace the chronology of developments in breast imaging technologies that are used for diagnosis and staging of breast cancer, including mammography, ultrasonography, magnetic resonance imaging, computed tomography, and positron emission tomography. We explore factors that affected clinical acceptance and utilization of these technologies from discovery to clinical use, including milestones in peer-reviewed publication, US Food and Drug Administration approval, reimbursement by payers, and adoption into clinical guidelines. The factors driving utilization of new imaging technologies are mainly driven by regulatory approval and reimbursement by payers rather than evidence that they provide benefits to patients. Comparative effectiveness research can serve as a useful tool to investigate whether these imaging modalities provide information that improves patient outcomes in real-world settings.

Figure 1

Milestones in mammography. Abbreviations: MM, mammography; HIP, Health Insurance Plan of Greater New York; FDA, US Food and Drug Administration; MDA, Medical Device Amendments of 1976; CMS, Centers for Medicare and Medicaid Services; CAD, computer-aided detection; NCCN, National Comprehensive Cancer Network; FFDM, full field digital mammography; DMIST, Digital Mammographic Imaging Screening Trial.

Figure 2

Milestones in ultrasound imaging of the breast. Abbreviations: CMS, Centers for Medicare and Medicaid Services; FDA, US Food and Drug Administration; MDA, Medical Device Amendments of 1976.

Figure 3

Milestones in MRI of the breast. Abbreviations: MRI, magnetic resonance imaging; FDA, US Food and Drug Administration; CMS, Centers for Medicare and Medicaid Services; MRS, magnetic resonance spectroscopy; Gd, gadolinium; NCCN, National Comprehensive Cancer Network.

Figure 4

Milestones in computed tomography (CT) imaging of the breast. Abbreviations: CT, computed tomography; FDA, US Food and Drug Administration; MDA, Medical Device Amendments of 1976; CMS, Centers for Medicare and Medicaid Services; NCCN, National Comprehensive Cancer Network.

Figure 5

Milestones in PET imaging of the breast. Abbreviations: PET, positron emission tomography; FDA, US Food and Drug Administration; MDA, Medical Device Amendments of 1976; FDG, fluorodeoxyglucose; PET/CT, positron emission tomography/computed tomography; CMS, Centers for Medicare and Medicaid Services; NCCN, National Comprehensive Cancer Network.