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Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Sponsor: 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.
Key Details
Gender
FEMALE
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-10-14
Completion Date
2026-03-31
Last Updated
2025-10-22
Healthy Volunteers
No
Conditions
Interventions
CEM Software in New Mammography Device
All subjects enrolled in the study will undergo a CEM exam.
Locations (2)
Solis Mammography Memorial Village
Houston, Texas, United States
Washington Radiology Sterling
Sterling, Virginia, United States