Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01433640

Run by

Hologic, Inc.

People needed

30

Starts

2011-07-01

Expected to finish

2014-02-01

Last updated by the study team

2015-03-18

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Rose Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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