Prospective Case Collection Study for New Mammography Technologies

Running, not enrolling · Not applicable

Conditions studied: Mammography

In brief

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.

Key facts

Study ID

NCT05199701

Run by

Hologic, Inc.

People needed

7500

Starts

2021-12-10

Expected to finish

2026-11-05

Last updated by the study team

2026-06-22

Who can join

Age: 35 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Southwest Medical Imaging — Gilbert, Arizona, United States
• Scottsdale Medical Imaging LTD — Scottsdale, Arizona, United States
• Miami Breast Institute — Coral Gables, Florida, United States
• Diagnostic Centers of America Palm Beach Gardens — Palm Beach Gardens, Florida, United States
• Diagnostic Centers of America West Palm Beach — West Palm Beach, Florida, United States
• Baptist Health — Louisville, Kentucky, United States
• Progressive Radiology — Bel Air, Maryland, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Elizabeth Wendy Breast Care — Rochester, New York, United States
• Solis Mammography Greensboro — Greensboro, North Carolina, United States
• Solis Mammography Columbus — Columbus, Ohio, United States
• Solis Mammography Burleson — Burleson, Texas, United States
• Washington Radiology — Arlington, Virginia, United States
• Washington Radiology — Sterling, Virginia, United States

Full record on ClinicalTrials.gov

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