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

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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).
We found this trial at
1
site
4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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mi
from
Denver, CO
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