NCT05199701

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

4.3 years

First QC Date

December 16, 2021

Last Update Submit

August 26, 2025

Conditions

Mammography

Outcome Measures

Primary Outcomes (2)

  • Clinically acceptable image quality of the Investigational Device.

    Questionnaire will be used to measure outcomes

    4 years

  • Mammograms can be safety acquired on the Investigational Device.

    Will be determined using the AE assessment.

    4 years

Secondary Outcomes (2)

  • The ease of positioning and usability of the Investigational Device.

    4 years

  • Subject assessment of comfort of the Investigational Device.

    4 years

Study Arms (1)

Investigational Mammogram Exam

EXPERIMENTAL
Device: Mammography

Interventions

MammographyDEVICE

All subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device.

Investigational Mammogram Exam

Eligibility Criteria

Age35 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

ACTIVE NOT RECRUITING

Southwest Medical Imaging

Gilbert, Arizona, 85297, United States

ACTIVE NOT RECRUITING

Scottsdale Medical Imaging LTD

Scottsdale, Arizona, 85251, United States

ACTIVE NOT RECRUITING

Miami Breast Institute

Coral Gables, Florida, 33146, United States

RECRUITING

Diagnostic Centers of America Palm Beach Gardens

Palm Beach Gardens, Florida, 33410, United States

TERMINATED

Diagnostic Centers of America West Palm Beach

West Palm Beach, Florida, 33401, United States

TERMINATED

Baptist Health

Louisville, Kentucky, 40207, United States

ACTIVE NOT RECRUITING

Progressive Radiology

Bel Air, Maryland, 21014, United States

ACTIVE NOT RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

ACTIVE NOT RECRUITING

Elizabeth Wendy Breast Care

Rochester, New York, 14620, United States

ACTIVE NOT RECRUITING

Solis Mammography Greensboro

Greensboro, North Carolina, 27401, United States

ACTIVE NOT RECRUITING

Solis Mammography Columbus

Columbus, Ohio, 43214, United States

ACTIVE NOT RECRUITING

Solis Mammography Burleson

Burleson, Texas, 76028, United States

ACTIVE NOT RECRUITING

Washington Radiology

Arlington, Virginia, 22201, United States

ACTIVE NOT RECRUITING

Washington Radiology

Sterling, Virginia, 20166, United States

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Santina Wendling

CONTACT

202-821-9375Santina.Wendling@hologic.com

Alexis Cooper

CONTACT

281-868-1140Alexis.Cooper@Hologic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 20, 2022

Study Start

December 10, 2021

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

To protect participant privacy and comply with the IRB. The IRB did not approved the secondary use of IPD at the time the protocol was approved.

Locations

US(15)