Prospective Case Collection Study for New Mammography Technologies

Mammography Clinical Trial

Official title:

Prospective Case Collection Study for New Mammography Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199701
• Other study ID #: 20-08
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Hologic, Inc.
• Contact: Alexis Cooper
• Phone: 2818681140
• Email: Alexis.Cooper[@]Hologic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 100 Years

Eligibility

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 is wheelchair bound and cannot stand independently
• Subject has breast implants, cardiac pacemakers or IV ports in the mammography field of view
• Subject previously participated in the study

Related Conditions & MeSH terms

• Mammography

Intervention

Device:
• Mammography
Hologic pre-market Mammography

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically acceptable image quality of the Investigational Device.	Questionnaire will be used to measure outcomes	4 years
Primary	Mammograms can be safety acquired on the Investigational Device.	Will be determined using the AE assessment.	4 years
Secondary	The ease of positioning and usability of the Investigational Device.	Questionnaire will be used to measure outcomes	4 years
Secondary	Subject assessment of comfort of the Investigational Device.	Questionnaire will be used to measure outcomes	4 years