Computed Tomography Laser Mammography Breast Imaging Device

Imaging Diagnostic Systems600 enrolled

Overview

The purpose of this study is to evaluate the sensitivity and specificity of the CTLM system when used adjunctively with mammography compared to mammography alone in the heterogeneously and extremely dense breast population.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * 21 and over * Heterogeneously or extremely dense breast * Schedule for biopsy * Gave informed consent Exclusion Criteria: * Mammogram not performed within the last 60 days * Open lesions on the breast * Previous breast biopsy within 60 days of the CTLM scan * Surgical deformity of breasts * Commercial Tattoos * Protoporphyria * Lactating

Central Contacts

Debra Wood

CONTACT

954-581-9800 dwood@imds.com

Data from ClinicalTrials.gov

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