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

Hologic

Status

Enrolling

Conditions

Breast Screening

Treatments

Device: CEM Exam in Investigational Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT06636539

20-43

Details and patient eligibility

About

This is a prospective, single-center image case collection study to acquire de-identified contrast-enhanced breast images on the Investigational Device to support continuing 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.

Full description

Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography with the Investigational Device. 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 CEM imaging acquired in the Investigational Device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.

Enrollment

75 estimated patients

Sex

Female

Ages

35+ years old

Volunteers

No Healthy Volunteers

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.