Actively Recruiting
Prospective Case Collection Study for New Mammography Technologies
Led by Hologic, Inc. · Updated on 2025-09-03
7500
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new mammography device to assess its safety, effectiveness, and usefulness in breast cancer screening and diagnosis. This study aims to support further development of this investigational technology by collecting prospective case data. The trial is sponsored by Hologic, Inc. and involves female participants who need a screening or diagnostic mammogram or breast biopsy. Participants will undergo an investigational mammogram exam using the new device. The study focuses on capturing mammograms safely and obtaining clinically acceptable image quality over a period of four years. Additionally, researchers will evaluate how easy it is to position patients and use the device, as well as participants' comfort during the exam. During the study, participants will have mammograms performed with the investigational device while researchers monitor image quality and safety. Comfort and usability assessments will also be collected. The trial includes a safety follow-up over four years to ensure participant well-being. Eligible women aged 35 to 100 years can join, and the total participation time will depend on their scheduled exams and follow-up evaluations.
CONDITIONS
Brief Title
Prospective Case Collection Study for New Mammography Technologies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 4 years
Participants who are indicated for a screening or diagnostic mammogram or breast biopsy undergo an investigational exam using a new mammography device.
1 visit per indicated mammogram or biopsy
Duration - Up to 4 years
Participants are observed to assess image quality, safety, usability, and comfort of the investigational mammography device over time.
Periodic follow-up as part of ongoing evaluation
Trial Site Locations
Total: 15 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Active, Not Recruiting
2
Southwest Medical Imaging
Gilbert, Arizona, United States, 85297
Active, Not Recruiting
3
Scottsdale Medical Imaging LTD
Scottsdale, Arizona, United States, 85251
Active, Not Recruiting
4
Miami Breast Institute
Coral Gables, Florida, United States, 33146
Actively Recruiting
5
Diagnostic Centers of America Palm Beach Gardens
Palm Beach Gardens, Florida, United States, 33410
Terminated
6
Diagnostic Centers of America West Palm Beach
West Palm Beach, Florida, United States, 33401
Terminated
7
Baptist Health
Louisville, Kentucky, United States, 40207
Active, Not Recruiting
8
Progressive Radiology
Bel Air, Maryland, United States, 21014
Active, Not Recruiting
9
Corewell Health
Grand Rapids, Michigan, United States, 49503
Active, Not Recruiting
10
Elizabeth Wendy Breast Care
Rochester, New York, United States, 14620
Active, Not Recruiting
11
Solis Mammography Greensboro
Greensboro, North Carolina, United States, 27401
Active, Not Recruiting
12
Solis Mammography Columbus
Columbus, Ohio, United States, 43214
Active, Not Recruiting
13
Solis Mammography Burleson
Burleson, Texas, United States, 76028
Active, Not Recruiting
14
Washington Radiology
Arlington, Virginia, United States, 22201
Active, Not Recruiting
15
Washington Radiology
Sterling, Virginia, United States, 20166
Active, Not Recruiting
Research Team
S
Santina Wendling
A
Alexis Cooper
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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