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

Hologic

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT01433640

11-01

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

25+ years old

Volunteers

No Healthy Volunteers

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).