Status:
COMPLETED
Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study
Lead Sponsor:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
25+ years
Brief Summary
This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast c...
Eligibility Criteria
Inclusion
- Subject is a female of any race and ethnicity.
- Subject is at least 25 years old
- Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies
- Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist
- \>50% of the biopsied cancer mass must remain following biopsy OR
- A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy
Exclusion
- Subject is unable or unwilling to undergo informed consent
- Subject has breast implant in the breast to be imaged
- Subject is pregnant
- Subject is breast feeding or lactating
- Subject has a known allergy to gadolinium contrast agents.
- Subject has a contraindication for MRI.
- Subject suspected to be at risk to complication from the contrast agents.
- Subject has a documented renal insufficiency,
- Subject requires renal dialysis.
- Subject has had a prior reaction to iodinated contrast.
- Subject has had a prior episode of anaphylactic reaction to any substance.
- Subject has taken metformin (Glucophage) within 48 hours of study procedures.
- Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01433640
Start Date
July 1 2011
End Date
February 1 2014
Last Update
March 18 2015
Active Locations (1)
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1
Rose Medical Center
Denver, Colorado, United States, 80220