Active, not recruiting
Not applicable
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
Condition(s) studied
Breast Screening
Investigational drug(s) / intervention(s)
CEM Software in New Mammography Device
CEM Software in New Mammography Device: All subjects enrolled in the study will undergo a CEM exam.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Number of subjects (cases) with lesions — 18 months
Number of subjects with contrast-enhanced breast images containing lesions as assessed by radiologists' image quality review
Trial sites (2)
| Facility | City | Region | Status |
| Solis Mammography Memorial Village |
Houston |
Texas |
|
| Washington Radiology Sterling |
Sterling |
Virginia |
|
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