NCT06636539

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion. Thus, to assess the clinical efficacy of the Hologic CEM software I-View in a new mammography device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.

Conditions

• Breast Screening

Interventions

Type	Name	Description
DEVICE	CEM Software in New Mammography Device	All subjects enrolled in the study will undergo a CEM exam.

Timeline

• Start date: 2024-10-14
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-10-10
• Last updated: 2025-10-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study