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

Conditions

• Breast Screening

Eligibility Criteria

Sex

FEMALE

Age

35 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CEM Software in New Mammography Device — DEVICE
  All subjects enrolled in the study will undergo a CEM exam.

Study Details

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 Dates

Start date

Oct 14, 2024

Status verified

Oct 2025

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

• Experimental: CEM Investigational Exam

Primary Outcome Measure

Number of subjects (cases) with lesions [ Time Frame: 18 months ]

Central Contacts

• Muhammad Waqas Director of Global Clinical Affairs
  +15088267183
  [email protected]
• Alexis Cooper Senior Manager, Clinical Development-Clinical Affairs
  +1281-868-1140
  [email protected]

Locations (2)

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