Prospective Case Collection Study for New Mammography Technologies

Last updated: August 26, 2025
Sponsor: Hologic, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Mammography

Clinical Study ID

NCT05199701
20-08
  • Ages 35-100
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Subject is pregnant or thinks she may be pregnant

  • Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports inthe mammography field of view.

  • Subject previously participated in the study.

Study Design

Total Participants: 7500
Treatment Group(s): 1
Primary Treatment: Mammography
Phase:
Study Start date:
December 10, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Southwest Medical Imaging

    Gilbert, Arizona 85297
    United States

    Completed

  • Scottsdale Medical Imaging LTD

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert 5295903, Arizona 5551752 85234
    United States

    Site Not Available

  • Southwest Medical Imaging

    Gilbert 5295903, Arizona 5551752 85297
    United States

    Site Not Available

  • Scottsdale Medical Imaging LTD

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Site Not Available

  • Miami Breast Institute

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Diagnostic Centers of America Palm Beach Gardens

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • Diagnostic Centers of America West Palm Beach

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Miami Breast Institute

    Coral Gables 4151871, Florida 4155751 33146
    United States

    Active - Recruiting

  • Diagnostic Centers of America Palm Beach Gardens

    Palm Beach Gardens 4167519, Florida 4155751 33410
    United States

    Terminated

  • Diagnostic Centers of America West Palm Beach

    West Palm Beach 4177887, Florida 4155751 33401
    United States

    Terminated

  • Baptist Health

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Baptist Health

    Louisville 4299276, Kentucky 6254925 40207
    United States

    Site Not Available

  • Progressive Radiology

    Bel Air, Maryland 21014
    United States

    Site Not Available

  • Progressive Radiology

    Bel Air 4348240, Maryland 4361885 21014
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Elizabeth Wendy Breast Care

    Rochester, New York 14620
    United States

    Site Not Available

  • Elizabeth Wendy Breast Care

    Rochester 5134086, New York 5128638 14620
    United States

    Site Not Available

  • Solis Mammography Greensboro

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Solis Mammography Greensboro

    Greensboro 4469146, North Carolina 4482348 27401
    United States

    Site Not Available

  • Solis Mammography Columbus

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Solis Mammography Columbus

    Columbus 4509177, Ohio 5165418 43214
    United States

    Site Not Available

  • Solis Mammography Burleson

    Burleson, Texas 76028
    United States

    Site Not Available

  • Solis Mammography Burleson

    Burleson 4677551, Texas 4736286 76028
    United States

    Site Not Available

  • Washington Radiology

    Arlington, Virginia 22201
    United States

    Site Not Available

  • Washington Radiology

    Sterling, Virginia 20166
    United States

    Site Not Available

  • Washington Radiology

    Arlington 4744709, Virginia 6254928 22201
    United States

    Site Not Available

  • Washington Radiology

    Sterling 4787534, Virginia 6254928 20166
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.