Actively Recruiting
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Led by Hologic, Inc. · Updated on 2025-10-22
75
Participants Needed
2
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
CONDITIONS
Official Title
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female of any race and ethnicity
- At least 35 years old
- Has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or biopsy
- Able to read, understand, and sign the study-specific informed consent form
You will not qualify if you...
- Unable or unwilling to give informed consent or requires a legally authorized representative for consent
- Has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view on the breast of interest
- Had an interventional procedure in the same breast as the suspicious finding within the last 6 months
- Pregnant or presumed pregnant
- Breastfeeding
- Actively receiving chemotherapy for any cancer
- At risk of complications from iodinated contrast agent, including renal insufficiency or being on dialysis
- Known allergy to iodinated contrast
- Known allergy to gadolinium contrast agents
- At increased risk for complications related to renal function, anticoagulant therapy, or bleeding disorders based on physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Solis Mammography Memorial Village
Houston, Texas, United States, 77024
Active, Not Recruiting
2
Washington Radiology Sterling
Sterling, Virginia, United States, 20166
Actively Recruiting
Research Team
M
Muhammad Waqas Director of Global Clinical Affairs
CONTACT
A
Alexis Cooper Senior Manager, Clinical Development-Clinical Affairs
CONTACT
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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