Ireland
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Active, not recruiting Not applicable

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

NCT06636539 · tracked via the Priya Life Science USA tracker
Sponsor
Hologic, Inc
Phase
Not applicable
Started
2024-10-14
Last updated
2026-06-22

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

Sex
FEMALE
Min age
35 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Solis Mammography Memorial Village Houston Texas
Washington Radiology Sterling Sterling Virginia

More Hologic, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06636539 on ClinicalTrials.gov ↗ ← All trials in the USA