Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 25 - Any |
Updated: | 11/23/2013 |
Start Date: | July 2011 |
End Date: | September 2013 |
Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study
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 cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study
will then be used to design additional studies.
Inclusion Criteria:
- 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 Criteria:
- 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).
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Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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