Prospective Case Collection Study for New Mammography Technologies
Hologic, Inc.
Summary
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.
Eligibility
- Age range
- 35–100 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Subject is female of any race and ethnicity. * Subject is at least 35 years old. * Subject is indicated for a screening or diagnostic mammogram or breast biopsy. Exclusion Criteria: * Subject is pregnant or thinks she may be pregnant * Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view. * Subject previously participated in the study.
Interventions
- DeviceMammography
All subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device.
Locations (15)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Southwest Medical ImagingGilbert, Arizona
- Scottsdale Medical Imaging LTDScottsdale, Arizona
- Miami Breast InstituteCoral Gables, Florida
- Diagnostic Centers of America Palm Beach GardensPalm Beach Gardens, Florida
- Diagnostic Centers of America West Palm BeachWest Palm Beach, Florida