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

Launched by HOLOGIC, INC. · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device that uses a special type of mammography called contrast-enhanced mammography. This imaging technique helps to take clearer pictures of the breast, which can assist doctors in evaluating suspicious findings or abnormalities detected in previous mammograms. The goal of the study is to gather breast images that will help improve this technology.

To participate, women who are at least 35 years old and have a concerning finding on their mammogram may be eligible. Participants must be able to understand and sign a consent form explaining the study. However, women with certain conditions, like breast implants or those who are pregnant, cannot take part in this trial. If you decide to join, you will undergo the imaging procedure using the investigational device, and your images will be used to support further development of this technology. It’s a way to help improve breast screening for women in the future.

Gender

FEMALE

Eligibility criteria

• 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.