Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Hologic, Inc.
Summary
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
Description
Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnos…
Eligibility
- Age range
- 35+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Subject is female of any race and ethnicity. * Subject is at least 35 years old * Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure. * Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them. Exclusion Criteria: * Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent. * Subject…
Interventions
- DeviceCEM Software in New Mammography Device
All subjects enrolled in the study will undergo a CEM exam.
Locations (2)
- Solis Mammography Memorial VillageHouston, Texas
- Washington Radiology SterlingSterling, Virginia