Evaluating new mammography technologies for breast cancer screening
Prospective Case Collection Study for New Mammography Technologies
NA · Hologic, Inc. · NCT05199701
This study is testing a new mammography device to see if it is safe and effective for women getting screened for breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 7500 (estimated) |
| Ages | 35 Years to 100 Years |
| Sex | Female |
| Sponsor | Hologic, Inc. (industry) |
| Locations | 15 sites (Gilbert, Arizona and 14 other locations) |
| Trial ID | NCT05199701 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of a new investigational mammography device in the context of breast cancer screening and diagnosis. It involves collecting prospective case data from female participants who are indicated for a mammogram or breast biopsy. The goal is to support the ongoing development of this technology by evaluating its clinical utility in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are females aged 35 and older who require a screening or diagnostic mammogram.
Not a fit: Patients who are pregnant, have breast implants, or have other specified medical devices in the mammography field of view may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved breast cancer screening methods, enhancing early detection and diagnosis.
How similar studies have performed: Other studies evaluating new mammography technologies have shown promise, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gilbert, Arizona and 14 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Southwest Medical Imaging — Gilbert, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Scottsdale Medical Imaging LTD — Scottsdale, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Miami Breast Institute — Coral Gables, Florida, United States (RECRUITING)
- Diagnostic Centers of America Palm Beach Gardens — Palm Beach Gardens, Florida, United States (TERMINATED)
- Diagnostic Centers of America West Palm Beach — West Palm Beach, Florida, United States (TERMINATED)
- Baptist Health — Louisville, Kentucky, United States (ACTIVE_NOT_RECRUITING)
- Progressive Radiology — Bel Air, Maryland, United States (ACTIVE_NOT_RECRUITING)
- Corewell Health — Grand Rapids, Michigan, United States (ACTIVE_NOT_RECRUITING)
- Elizabeth Wendy Breast Care — Rochester, New York, United States (ACTIVE_NOT_RECRUITING)
- Solis Mammography Greensboro — Greensboro, North Carolina, United States (ACTIVE_NOT_RECRUITING)
- Solis Mammography Columbus — Columbus, Ohio, United States (ACTIVE_NOT_RECRUITING)
- Solis Mammography Burleson — Burleson, Texas, United States (ACTIVE_NOT_RECRUITING)
- Washington Radiology — Arlington, Virginia, United States (ACTIVE_NOT_RECRUITING)
- Washington Radiology — Sterling, Virginia, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Santina Wendling
- Email: Santina.Wendling@hologic.com
- Phone: 202-821-9375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mammography