Collecting breast images using a new contrast-enhanced mammography device

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

This study is testing a new imaging device that uses a special contrast dye to see if it can improve breast images for women over 35 who have been found to have breast abnormalities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 35 Years and up
• Sex: Female
• Sponsor: Hologic, Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06636539 on ClinicalTrials.gov

What this trial studies

This study aims to collect de-identified contrast-enhanced breast images using an investigational device to support the development of new imaging technology. The approach involves administering intravenous iodinated contrast to enhance the visibility of suspicious findings on mammograms. Eligible participants are women aged 35 and older who have been identified with breast abnormalities and are scheduled for further diagnostic exams or biopsies. The collected images will help assess the clinical efficacy and image quality of the new contrast-enhanced mammography technique.

Who should consider this trial

Good fit: Ideal candidates are women aged 35 and older with suspicious findings on a mammogram who require further diagnostic evaluation.

Not a fit: Patients who are pregnant, breastfeeding, or actively undergoing cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of breast cancer detection and diagnosis.

How similar studies have performed: Other studies have shown promise with contrast-enhanced mammography techniques, indicating potential for success in this approach.

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.

Where this trial is running

Houston, Texas and 1 other locations

• Solis Mammography Memorial Village — Houston, Texas, United States (ACTIVE_NOT_RECRUITING)
• Washington Radiology Sterling — Sterling, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Chirag Parghi, MD — Solis Mammography
• Study coordinator: Muhammad Waqas Director of Global Clinical Affairs

Conditions: Breast Screening, CEM, Contrast-Enhanced Mammography, Contrast, Diagnostic mammogram, Mammography, Mammogram