Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device

Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device

This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.

Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion.

Thus, to assess the clinical efficacy of the Hologic CEM software I-View in a new mammography device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.

Inclusion Criteria:

• Subject is female of any race and ethnicity.
• Subject is at least 35 years old
• Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
• Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them.

Exclusion Criteria:

• Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
• Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
• Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
• Subject is pregnant or presumed to be pregnant.
• Subject is breastfeeding.
• Subject is actively being treated for cancer of any type with chemotherapy
• Subject is suspected to be at risk of complications from the iodinated contrast agent. These include contra-indications of standard iodinated contrast agents, such as the subject having renal insufficiency) and the subject being on dialysis.
• Subject has had a prior reaction to iodinated contrast; thus, a known allergy to iodinated contrast.
• Subject has had a prior reaction to gadolinium contrast agents; thus, a known allergy to gadolinium contrast.
• Subject who, based on the physician's judgment, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.