Prospective Case Collection Study for New Mammography Technologies

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.

Study Overview

• Status: Recruiting
• Conditions: Mammography
• Intervention / Treatment: Device: Mammography

• Study Type: Interventional
• Enrollment (Estimated): 7500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Santina Wendling; Phone Number: 202-821-9375; Email: Santina.Wendling@hologic.com
• Study Contact Backup: Name: Alexis Cooper; Phone Number: 281-868-1140; Email: Alexis.Cooper@Hologic.com

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Active, not recruiting
      • Banner MD Anderson Cancer Center
    • Gilbert, Arizona, United States, 85297
      • Active, not recruiting
      • Southwest Medical Imaging
    • Scottsdale, Arizona, United States, 85251
      • Active, not recruiting
      • Scottsdale Medical Imaging LTD
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Miami Breast Institute
      • Contact: Geena Thomas
    • Palm Beach Gardens, Florida, United States, 33410
      • Terminated
      • Diagnostic Centers of America Palm Beach Gardens
    • West Palm Beach, Florida, United States, 33401
      • Terminated
      • Diagnostic Centers of America West Palm Beach
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Active, not recruiting
      • Baptist Health
  • Maryland
    • Bel Air, Maryland, United States, 21014
      • Active, not recruiting
      • Progressive Radiology
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Active, not recruiting
      • Corewell Health
  • New York
    • Rochester, New York, United States, 14620
      • Active, not recruiting
      • Elizabeth Wendy Breast Care
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Active, not recruiting
      • Solis Mammography Greensboro
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Active, not recruiting
      • Solis Mammography Columbus
  • Texas
    • Burleson, Texas, United States, 76028
      • Active, not recruiting
      • Solis Mammography Burleson
  • Virginia
    • Arlington, Virginia, United States, 22201
      • Active, not recruiting
      • Washington Radiology
    • Sterling, Virginia, United States, 20166
      • Active, not recruiting
      • Washington Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Mammogram Exam	Device: Mammography; All subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ease of positioning and usability of the Investigational Device.	Questionnaire will be used to measure outcomes	4 years
Subject assessment of comfort of the Investigational Device.	Questionnaire will be used to measure outcomes	4 years

Collaborators and Investigators

• Sponsor: Hologic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Radiography; Mammography
• Other Study ID Numbers: 20-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes