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

Running, not enrolling · Not applicable

Conditions studied: Breast Screening

In brief

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.

Key facts

Study ID

NCT06636539

Run by

Hologic, Inc.

People needed

75

Starts

2024-10-14

Expected to finish

2026-11-05

Last updated by the study team

2026-06-22

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Solis Mammography Memorial Village — Houston, Texas, United States
• Washington Radiology Sterling — Sterling, Virginia, United States

Full record on ClinicalTrials.gov

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